Netarsudil mesylate - Alcon
Alternative Names: AR-13224; AR13324; Netarsudil mesylate; Netarsudil ophthalmic solution - Alcon; Rhokiinsa; Rhopressa; STN-1013900Latest Information Update: 22 Mar 2023
At a glance
- Originator Duke University Medical Center
- Developer Alcon; Cornea Research Foundation of America; Santen Pharmaceutical
- Class Antiglaucomas; Eye disorder therapies; Isoquinolines; Small molecules
- Mechanism of Action Rho-associated kinase inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes - Glaucoma
Highest Development Phases
- Marketed Ocular hypertension; Open-angle glaucoma
- Phase II Fuchs' endothelial dystrophy
- No development reported Neurological disorders
Most Recent Events
Development Overview
Introduction
Netarsudil mesylate ophthalmic solution has been developed by Alcon (previously Aerie Pharmaceuticals), under a licence from Duke University Medical Center, for the reduction of intraocular pressure in open-angle glaucoma, ocular hypertension and for reducing or resolving corneal edema in Fuchs' endothelial dystrophy. The drug is a Rho kinase inhibitor, which reduces IOP by increasing the outflow of aqueous humour through the trabecular meshwork route. The drug is characterised by a long duration of effect which allows for once-daily dosing, a more convenient dosing schedule compared with other multiple-daily-dose anti-glaucomas. Netarsudil mesylate is launched in the US and Sweden, approved in the European Union and Thailand and Asia for the treatment of open-angle glaucoma and ocular hypertension. Clinical development for open-angle glaucoma and ocular hypertension is underway in Canada and Japan. Clinical development for Fuchs'-endothelial-dystrophy is underway in the US.
Netarsudil mesylate ophthalmic solution was also developed for neurological disorders. However, no recent reports of development have been identified for this indication.
Netarsudil mesylate emerged as a lead candidate from Aerie's anti-glaucoma therapeutics research programme [see ADIS Insight drug profile 800023495].
Alcon is seeking for collaborators to commercialize netarsudil mesylate (Rhokiinsa®) in Europe [1] .
In November 2022, Aerie Pharmaceuticals was acquired and merged into Alcon [2] .
In March 2023, Graybug inc. merged with CalciMedica to form CalciMedica [3] .
Company Agreements
In December 2021, Aerie Pharmaceuticals (now Alcon) and Santen expanded the exclusive development and commercialisation agreement for Rhopressa®/Rhokiinsa® (netarsudil ophthalmic solution) 0.02% and Rocklatan®/Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. The expanded collaboration includes Europe, Commonwealth of Independent States (CIS) countries, Africa, China, India, parts of Latin America and the Oceania countries. Under the terms of the agreement, Aerie will receive an upfront payment of $US88 million, and various development, regulatory and sales milestones of up to $US77 million. Aerie is also eligible to receive additional consideration in excess of 25% of the products’ net sales, such consideration consisting of the cost of products supplied to Santen from Aerie and a royalty for Aerie’s intellectual property. Santen will be responsible for sales, marketing and pricing decisions relating to the products. Santen will also be responsible for all development and commercialisation costs and activities related to the products in the territories covered by the agreement with the exception of a post-marketing clinical study to be conducted by Aerie in Europe for Roclanda®. Aerie will be responsible for the manufacture and supply of the products to Santen utilizing its Athlone, Ireland plant. In addition to customary termination rights for both parties, in the event that patents are issued that may prevent the commercialisation of the products in China, Santen would have the right to terminate the agreement for such country and require Aerie’s repayment of a portion of the upfront payment. In October 2020, Aerie Pharmaceuticals and Santen Pharmaceutical entered into a development and commercialization agreement for Rhopressa® and Rocklatan® in Japan, along with rights for several other Asian countries. Under the terms of the agreement, Aerie will receive an upfront payment of $US50 million, and various development and sales milestones of up to $US99 million. Aerie is also eligible to receive additional consideration in excess of 25% of the products’ net sales, such consideration consisting of the cost of products supplied to Santen from Aerie and a royalty for Aerie’s intellectual property. Santen will be responsible for sales, marketing and pricing decisions relating to the products. Santen will also be responsible for all development and commercialisation costs and activities related to the products in the territories covered by the agreement, however, Aerie and Santen will collaborate for the first phase III trial for Rhopressa® in Japan. In addition to customary termination rights for both parties, in the event that patents are issued that may prevent the commercialisation of the products, Santen would have the right to terminate the agreement and require Aerie’s repayment of a portion of the upfront payment, all development milestone payments, and a portion of the development expenses incurred by Santen. [4] [5] [6] [2]
In August 2015, Aerie and GrayBug entered into an agreement, which provides for a one-year research collaboration between the companies and an exclusive option for Aerie to license GrayBug technology for development and commercialisation of Aeries's sustained-release eye disorder therapeutics to be delivered to both the front and back of the eye. The research collaboration allows development of long-term sustained release netarsudil mesylate delivered to the anterior chamber of the eye for the treatment of glaucoma and ocular hypertension. Under the terms of the agreement, GrayBug is eligible for development milestone payments and royalties from Aerie on commercialisation of any products arising from the collaboration [7] .
Key Development Milestones
In April 2018, netarsudil mesylate 0.02% ophthalmic solution (Rhopressa®) was launched in the US, for the treatment of patients with open-angle glaucoma or ocular hypertension [8] . Netarsudil mesylate 0.02% solution was approved by the US FDA in December 2017, for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The FDA approval decision was made two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018 [9] . In September 2020, Aerie Pharmaceuticals announced that its sterile fill production facility in Ireland has received approval from the US FDA for production of Rhopressa® (netarsudil ophthalmic solution) 0.02% for commercial distribution in the US. This approval comes following the FDA review of the NDA Prior Approval Supplement (PAS), which added the Athlone production facility as a drug product manufacturer for Rhopressa® [10] . In October 2017, Aerie Pharmaceuticals announced that the Dermatologic and Ophthalmic Drugs Advisory Committee of the US FDA voted in favour of the drug. The committee affirmed by a 10 to 0 vote that the clinical trials supported the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension and by a 9 to 1 vote that the efficacy of netarsudil ophthalmic solution, demonstrated in the clinical trials, outweighed the safety risks identified for the drug product. Additionally, there was general discussion on suggestions regarding the draft product labelling proposed by the FDA, which will be determined based on follow-on discussions between Aerie and the FDA [11] . In May 2017, the US FDA completed 60-day review of the netarsudil NDA and determined that the application is sufficiently complete to permit a substantive review and planning to hold an advisory committee [12] . In February 2017, Aerie Pharmaceuticals re-submitted the New Drug Application (NDA) to the US FDA, seeking approval of netarsudil mesylate ophthalmic solution (0.02%), for the treatment of patients with glaucoma or ocular hypertension [13] [14] . In October 2016, the company had withdrawn the NDA that was submitted earlier in September 2016, due to a third party manufacturing facility not being ready for pre-approval inspection by the FDA. The NDA submission was supported by data from the two phase III studies ROCKET 1 and pivotal ROCKET 2 [see below] [15] [16] . The company also included 90-day efficacy data from ROCKET 4 trial [see below] and Mercury 1 registrational study of latanoprost/netarsudil mesylate ophthalmic solution (RoclatanTM) [see Adis Insight Drug profile 800038899], as supportive data, in the re-submitted NDA [14] [17] [18] [19] . In August 2017, Aerie Pharmaceuticals reported that, its contract drug manufacturer has received a Complete Response Letter from the US FDA, referring to a Current Good Manufacturing Practice (CGMP) inspection at the facility. However, the company anticipates that the issues will be resolved before the PDUFA date of netarsudil mesylate ophthalmic solution (0.02%) [20] .
In January 2023, netarsudil mesylate 0.02% ophthalmic solution received marketing approval in Thailand for the treatment of patients with open-angle glaucoma or ocular hypertension (Santen Pharmaceutical pipeline, February 2023).
In February 2023, Santen Pharmaceutical launched netarsudil ophthalmic solution (Rhokiinsa®) in Sweden for the treatment of open-angle glaucoma or ocular hypertension (Santen Pharmaceutical pipeline, July 2023). In November 2019, the European Commission granted marketing authorisation for netarsudil ophthalmic solution 0.02% for the reduction of elevated intraocular pressure in adult patients with primary open-angle glaucoma or ocular hypertension. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for recommending approval of the marketing authorisation application (MAA) for netarsudil, in September 2019. The MAA was filed by Aerie Pharmaceuticals and was accepted by the EMA in October 2018 [21] [22] [23] .
In January 2023, Santen Pharmaceutical received approval in Asia for the treatment of open angle glaucoma and ocular hypertension (Santen Pharmaceutical pipeline; November 2023). In May 2022, Aerie Pharmaceuticals filed marketing authorization application of netarsudil ophthalmic solution open angle glaucoma or ocular hypertension in Asia (Santen Pharmaceutical pipeline, August 2022).
As of June 2021, Aerie Pharmaceuticals intends to initiate an additional four weeks trial and one 12 month safety phase III trial for open angle glaucoma or ocular hypertension in Japan [24] [1] .
In April 2020, Aerie Pharmaceuticals held a meeting with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to discuss phase III trial designs for netarsudil mesylate 0.02% ophthalmic solution (Rhopressa®), and continued to prepare for the trials. The company expects to initiate a phase III trial in Japan, along with exploring a collaboration with a potential partner in Japan to advance the drug's clinical development and commercialization activities in Japan [25] .
In July 2019, Cornea Research Foundation of America completed a phase III trial that evaluated netarsudil 0.02% solution in patients for the prevention of corticosteroid-induced intraocular pressure elevation (2017-003; NCT03248037). The randomized, double-masked, placebo-controlled study was initiated in September 2017, and enrolled 120 patients in the US [26] .
The phase III ROCKET 4 trial, completed in April 2017, achieved its primary efficacy endpoint with netarsudil 0.02% solution demonstrating non-inferiority compared to timolol, in reducing intraocular pressure in patients with glaucoma or ocular hypertension. In September 2015, Aerie initiated the trial to compare the safety and efficacy of netarsudil mesylate with timolol maleate ophthalmic solution in patients with open angle glaucoma or ocular hypertension in both eyes (AR-13324-CS304; NCT02558374). In June 2016, the randomised, double-blind trial completed enrolment of 700 patients in the US. The trial is expected to provide additional clinical and six-month safety data to support regulatory filings in Europe [27] [12] [28] [18] [29] . Positive six-month and 90-day topline efficacy and safety data were released by Aerie in April 2017 and October 2016, respectively [30] [15] [17] [31] .
The third safety-only registration Rocket 3 trial was completed in December 2016, that evaluated the safety and tolerability of netarsudil mesylate in patients with glaucoma or ocular hypertension, over 12 months (AR13324CS303; NCT02246764). The trial was initiated in August 2014 in Canada. Aerie had received a No Objection Letter from Health Canada for this study, in July 2014. The three phase III trials are designed to enrol approximately 1 300 patients in total in the US and Canada. In June 2015, the company reported that the US FDA has agreed that Aerie may change the primary endpoint range of this study. The company amended the primary endpoint range to include patients with baseline IOP ranging from above 20 mmHg to below 25 mmHg in the Rocket 4 trial [see above] [32] [33] [34] [35] [36] [37] [38] [31] .
The primary efficacy endpoint of the pivotal phase III ROCKET 2 trial, defined as demonstration of non-inferiority of once-daily netarsudil mesylate compared with twice-daily timolol, in patients with glaucoma or ocular hypertension, was met (AR-13324-CS302; NCT02207621). Aerie, in March 2016, completed the study that evaluated the safety and efficacy of netarsudil mesylate in lowering intraocular pressure. Enrolment of 756 patients was completed in Rocket 2 in March 2015 [39] [35] [40] [41] [42] [43] . In February 2016, Aerie reported positive interim results demonstrating netarsudil mesylate 0.02% maintained consistent IOP-lowering efficacy through 12 months [44] . Interim results, reported in September 2015, indicated non-inferiority of netarsudil mesylate, dosed once-daily and twice-daily, compared with twice-daily timolol [19] . Initial efficacy results for Rocket 1 and interim efficacy results for Rocket 2 were reported in April 2015 and September 2015 respectively [19] [45] [41] [40] .
Aerie Pharmaceuticals, in April 2015, reported that the phase III ROCKET 1 trial did not meet its primary efficacy endpoint of demonstrating non-inferiority lower intraocular pressure (IOP) for once-daily netarsudil mesylate, compared with timolol (AR-13324-CS301; NCT02207491). The phase III trial that was completed in April 2015, evaluated the efficacy of netarsudil mesylate in patients with glaucoma or ocular hypertension. The randomised trial was initiated in July 2014 and enrolment of 400 patients was completed in December 2014 [46] [47] [41] [48] [40] [35] [39] [49] .
In July 2021, Aerie Pharmaceuticals completed the phase III trial that evaluated the efficacy and safety of once daily netarsudil ophthalmic solution 0.02%, when compared with twice daily ripasudil hydrochloride hydrate ophthalmic solution 0.4%, in Japanese patients with primary open angle glaucoma or ocular hypertension (AR-13324-CS305; NCT04620135). In December 2020, Aerie Pharmaceuticals successfully dosed the first patient in the trial. The randomised, single-masked, randomised, parallel-group, four-week trial was initiated in November 2020 and enrolled 245 patients in Japan [50] . In June 2021, Aerie Pharmaceuticals announced the completion of patient enrolment in the phase III trial [24] . In October 2021, the company released updated data of the trial [51] .
In August 2021, Aerie Pharmaceuticals completed a phase II trial that evaluated the efficacy of netarsudil ophthalmic solution (two different dosing regimens,QD and BID) in reducing or resolving corneal edema in patients with Fuchs'-endothelial-dystrophy (NCT04498169; AR-13324-CS210). The randomised, open-label trail was initiated in September 2020 and enroled 40 patients in the US [52] .
In September 2019, Aerie Pharmaceuticals completed a phase II registrational study designed to evaluate the efficacy and systemic safety of netarsudil ophthalmic solution 0.01%, 0.02%, 0.04%, versus placebo, in patients with open angle glaucoma or ocular hypertension (AR-13324-CS208; NCT03844945). The randomised, double-blind, placebo-controlled trial, initiated in March 2019 completed enrollmnet of 215 Japaneese patients in July 2019. In November 2019, Aerie Pharmaceuticals announced positive topline data from the study. The company intends to meet with the Pharmaceutical and Medical Devices Agency of Japan to discuss these positive results and decide on the next steps for the phase III programme in Japan [53] [54] [55] [56] .
In April 2018, Aerie Pharmaceuticals completed a phase II trial that evaluated the effect of netarsudil ophthalmic solution on trabecular outflow facility, in participants with elevated intraocular pressure (NCT03233308; AR13324CS206). Evaluation of the mean change from baseline in the mean diurnal trabecular outflow facility was the defined primary endpoint of the trial. The double-blind, randomised, placebo-controlled trial was initiated in October 2017 and enrolled 20 patients in the US [57] .
In October 2018, Aerie Pharmaceuticals completed a phase II trial that evaluated the safety and effectiveness of netarsudil 0.02% and 0.04% ophthalmic solution in comparison with placebo in Japanese/Japanese-American subjects with elevated intraocular pressure (AR13324CS205; NCT03310580). Mean diurnal intraocular pressure within a 28 day treatment period by Goldman Applanation was assessed as the primary endpoint. The double-blind, randomised trial enrolled 42 patients in the US. The trial was designed in accordance with the requirements of Japan’s Pharmaceuticals and Medical Devices Agency for potential regulatory submission of netarsudil ophthalmic solution in Japan [27] . In January 2019, Aerie Pharmaceuticals announced positive topline results of the trial. Results demonstrated that the safety profile of netarsudil 0.02% and 0.04% ophthalmic solution were consistent with previous netarsudil trials [58] [59] .
Aerie completed a randomised, double-blind, 28-day phase IIb trial in June 2013, which assessed the efficacy and safety of two dose levels of netarsudil mesylate, compared to latanoprost, in patients with glaucoma or ocular hypertension (AR-13324-CS202; NCT01731002). The trial was initiated in November 2012 and enrolled 224 patients in the US. Positive results were reported in January 2014 which showed IOP lowering effect of netarsudil mesylate, irrespective of the patient’s baseline IOP [34] [60] [61] .
Aerie announced positive top-line results from a phase IIa study to evaluate the safety and efficacy of netarsudil mesylate in patients with glaucoma or ocular hypertension (AR-13324-CS201; NCT01528787). The seven-day, double-blind trial enrolled 80 patients in the US. The patients were randomised to receive one of three once-daily, morning doses of netarsudil mesylate or vehicle alone [62] [63] .
In November 2016, Aerie announced that treatment with netarsudil ophthalmic solution maintained the same clinically significant IOP lowering throughout the night as it did during the day in a phase II randomized, placebo controlled trial which was completed in October 2016 and conducted in 12 patients with open angle glaucoma and ocular hypertension (AR-13324-CS204; NCT02874846). The study was conducted in the US [64] [65] .
A phase I trial was reported to be completed in November 2013 in the US. The trial assessed ocular and systemic safety and systemic absorption of the drug in 18 healthy volunteers (AR13324CS101; NCT01997879). Top-line results were reported in January 2014. A potential new mechanism of action, the reduction of episcleral venous pressure, was theorised based on these results. Aerie is planning additional studies to assess the effect of netarsudil mesylate on this parameter [60] [66] .
In April 2016, Aerie completed a phase I trial, which evaluated the effect of netarsudil mesylate ophthalmic solution on aqueous humor dynamics in healthy volunteers, compared with placebo (AR-13324-CS102; NCT02406287). The randomised, double-blind trial was initiated in April 2015 and enrolled 10 patients in the US [67] .
In February 2015, netarsudil mesylate was shown to suppress the activity of profibrotic proteins, namely transforming growth factor beta 2 (TGF-beta 2) and connective tissue growth factor (CTGF) on human trabecular meshwork cells in an in vitro model. Additional results indicated that netarsudil mesylate increased the perfusion of the trabecular meshwork with aqueous humor to provide nutrients and antioxidants to tissues in the trabecular outflow pathway [68] .
Positive preclinical results confirming the effect of netarsudil mesylate on episcleral venous pressure were released in February 2014 [69] .
In March 2021, Aerie reported preclinical results of netarsudil mesylate in a mouse model of steroid-induced ocular hypertension [70] .
Financing information
In January 2018, Aerie Pharmaceuticals announced that it has commenced a registered underwritten public offering of $US75 million of shares of its common stock. The net proceeds will be used to fund expansion of its commercialisation programmes in North America for Rhopressa® and its clinical and commercialisation efforts beyond North America, further development of other potential pipeline opportunities, including activities to support the ongoing development of its retina programmes [71] [72] .
In June 2017, Aerie Pharmaceuticals raised $US125 million at-the-market program and upsized follow-on offering [73] . Earlier in May 2017, the company commenced a registered underwritten public offering of $US50 million of shares of its common stock. The company intends to use the net proceeds of the offering for the commercialisation activities of netarsudil mesylate in North America and beyond North America, its preclinical, clinical and manufacturing activities, also to expand its external business development programs [74] .
Aerie Pharmaceuticals, in September 2016 announced the pricing of a registered underwritten public offering of $US75 million of shares of its common stock. The offering was raised by $US25 million over the offering amount anticipated to be sold as previously announced. Additionally, the company has raised $US50 million separately through the completion and full utilization of an at-the-market (ATM) programme with Cantor Fitzgerald & Co. Earlier, in the same month, Aerie commenced a registered underwritten public offering of $US50 million of shares of its common stock. The net proceeds from the offerings will be utilised for the complete funding of commercialisation costs of netarsudil mesylate, execution of clinical trials in Japan and for continuation of preclinical studies in support of its product pipeline [75] [76] .
In September 2014, Aerie closed its $US125 million financing with Deerfield Management Company. Aerie intends to use the proceeds to complete clinical requirements and to market netarsudil mesylate, for development of latanoprost/netarsudil mesylate [see RDI Profile 800038899], and for general corporate purposes and strategic growth opportunities [77] .
In March 2011, Aerie closed a $US30 million Series B financing. The company planned to use the funding to support continued development of its portfolio of products for the treatment of glaucoma [78] .
Patent Information
Aerie Pharmaceuticals own the worldwide rights for Rocklatan®. Aerie Pharmaceuticals have patent protection for Rocklatan® in the United States and internationally through early 2034 and in Japan through 20378. Furthermore, company filed for patent protection in the United States and internationally through 2037 as reported by company in December 2021 [6] .
Aerie Pharmaceuticals has licensed a portfolio of intellectual property from Duke University Medical Center [79] .
Aerie Pharmaceuticals has patent protection for netarsudil mesylate, with U.S. Patent 8 450 344 and U.S. Patent 8 394 826, scheduled to expire in 2026 and 2030 respectively, covering the use and composition of matter and method of use (Aerie Pharmaceuticals 10-K, February 2015) [34] [80] .
Drug Properties & Chemical Synopsis
- Route of administration Ophthalmic
- Formulation Drops, Liquid, unspecified
- Class Antiglaucomas, Eye disorder therapies, Isoquinolines, Small molecules
- Target Rho-associated kinase
- Mechanism of Action Rho-associated kinase inhibitors
-
WHO ATC code
N07 (Other Nervous System Drugs)
S01E-X (Other antiglaucoma preparations)
-
EPhMRA code
N7 (Other CNS Drugs)
S1E2 (Miotics and antiglaucoma preparations, topical)
- Chemical name (S)-4-(3-amino-1-(isoquinolin-6-yl-amino)-1-oxopropan-2-yl) benzyl 2,4-dimethylbenzoate dimesylate
- Molecular formula C30 H35 N3 O9 S2
- SMILES C1=C(C=C(C(=C1)C(OCC1=CC=C(C=C1)C(C(NC1=CC2=C(C=C1)C=NC=C2)=O)CN)=O)C)C.S(=O)(=O)(C)O.S(=O)(=O)(C)O
-
Chemical Structure
- CAS Registry Number 1422144-42-0
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
glaucoma |
Arm Group Description |
Maleic acid |
|
|
glaucoma |
Arm Group Label |
Maleic acid |
|
|
glaucoma |
Official Title |
Maleic acid |
|
|
ocular hypertension |
Arm Group Description |
Maleic acid |
|
|
ocular hypertension |
Arm Group Label |
Maleic acid |
|
|
ocular hypertension |
Official Title |
Maleic acid |
|
|
open-angle glaucoma |
Arm Group Description |
Maleic acid |
|
|
open-angle glaucoma |
Arm Group Label |
Maleic acid |
|
|
open-angle glaucoma |
Official Title |
Maleic acid |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| Netarsudil mesylate - Alcon | FSH | Eligibility Criteria |
| Maleic acid | Arm Group Description, Arm Group Label, Official Title |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Fuchs' endothelial dystrophy | with corneal edema | - | Phase II | USA | Ophthalmic / Liquid | Alcon | 17 Sep 2020 |
| Neurological disorders | - | - | No development reported (Preclinical) | USA | unspecified / unspecified | Alcon | 21 Dec 2017 |
| Ocular hypertension | lowering intra-ocular pressure in patients with ocular hypertension | - | Marketed | USA | Ophthalmic / Drops | Alcon | 30 Apr 2018 |
| Ocular hypertension | - | - | Marketed | Sweden | Ophthalmic / Drops | Santen Pharmaceutical | 28 Feb 2023 |
| Ocular hypertension | - | - | Registered | Asia | Ophthalmic / Drops | Alcon, Santen Pharmaceutical | 31 Jan 2023 |
| Ocular hypertension | - | - | Registered | European Union, Iceland, Liechtenstein, Norway, Thailand | Ophthalmic / Drops | Alcon | 16 Feb 2023 |
| Ocular hypertension | - | - | Phase III | Canada, Japan | Ophthalmic / Drops | Alcon | 12 Nov 2020 |
| Ocular hypertension | Corticosteroid-induced intraocular pressure elevation | Prevention | Phase III | USA | Ophthalmic / Drops | Cornea Research Foundation of America | 05 Sep 2017 |
| Open-angle glaucoma | lowering intra-ocular pressure in patients with open-angle glaucoma | - | Marketed | USA | Ophthalmic / Drops | Alcon | 30 Apr 2018 |
| Open-angle glaucoma | - | - | Marketed | Sweden | Ophthalmic / Drops | Santen Pharmaceutical | 28 Feb 2023 |
| Open-angle glaucoma | - | - | Registered | Asia | Ophthalmic / Drops | Alcon, Santen Pharmaceutical | 31 Jan 2023 |
| Open-angle glaucoma | - | - | Registered | European Union, Iceland, Liechtenstein, Norway, Thailand | Ophthalmic / Drops | Alcon | 16 Feb 2023 |
| Open-angle glaucoma | - | - | Phase III | Canada, Japan | Ophthalmic / Drops | Alcon | 12 Nov 2020 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Duke University Medical Center | Originator | USA |
| Duke University Medical Center | Owner | USA |
| Santen Pharmaceutical | Market Licensee | Asia, China, Commonwealth of Independent States, Europe, India, Japan, Latin America, Oceania |
| Alcon | Licensee | World |
| CalciMedica | Technology Provider | USA |
| Cornea Research Foundation of America | Collaborator | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Alcon | Glaucoma | Unspecified | Europe | 05 May 2021 |
Brand Names
| Brand Name | Organisations | Indications | Countries |
|---|---|---|---|
| Rhokiinsa | Alcon | Ocular hypertension, Open-angle glaucoma | European Union |
| Rhopressa | Alcon | Ocular hypertension, Open-angle glaucoma | Japan, USA |
Scientific Summary
-
Adverse Events
Occasional:
Blurred vision; Conjunctival disorders; Corneal disorders; Hyperaemia
Adverse Events
Phase III
Interim safety data from the phase III ROCKET 2 trial showed that netarsudil mesylate was generally safe and well tolerated. The most common adverse event was hyperaemia, which was reported as increased in 30% of patients and regarded as mild in 76% of patients. At 12 month, 70% of patients with prior conjunctival hyperemia had no hyperemia. Other adverse events observed were conjunctival hemorrhages, cornea verticillata, instillation site pain and blurry vision (5%- 23%). Netarsudil mesylate dosed twice-daily generated higher incidence of adverse events [44] [19] [43] .
Netarsudil mesylate was generally safe and well tolerated in the phase III ROCKET 1 trial. The primary adverse event seen in 35% patients in the netarsudil mesylate arm, was hyperaemia and was regarded as a mild event. ROCKET 1 randomised 182 patients to the qd netarsudil mesylate cohort and 188 patients to the bid timolol cohort [46] .
The most common adverse event related to netarsudil as per the six-month and 90-day topline data from the phase III ROCKET 4 trial, was hyperaemia, or eye redness, which was reported in approximately 48% and 40% of patients, 75% and 85% of which was scored as mild, respectively. As per the six-month and 90-day analysis, other adverse events were reported in 5%-25% patients and 5%-12% of patients, respectively. There were no drug-related systemic or serious adverse events. Safety data observed over the six months were consistent with observations in previous netarsudil three-month and twelve-month phase III trials [30] [15] [31] .
Topline data of the randomised, single-masked, phase III trial in Japanese patients (n = 245) with primary open angle glaucoma or ocular hypertension showed that once daily netarsudil ophthalmic solution 0.02% was safe and well-tolerated. The most common treatment emergent adverse event was conjunctival hyperemia (54.9% of subjects with netarsudil 0.02% and 62.6% of subjects with ripasudil 0.4%). The majority of ocular adverse events were rated as mild [51] [50] .
Phase II
Netarsudil mesylate was well tolerated, following daily ophthalmic doses, during a phase IIa clinical study. Mild to moderate and transient ocular hyperaemia was observed following the first dose, which appeared to diminish by the end of the treatment period of seven days. The randomised, double-blind, dose-response trial enrolled 80 patients in the US with primary open-angled glaucoma or ocular hypertension [62] .
In a phase II trial in Japanese patients with open angle glaucoma and ocular hypertension, treatment with ophthalmic solution of netarsudil (0.01%, 0.02% and 0.04%) resulted conjunctival hyperemia as the most common adverse event (AE). This AE when measured with biomicroscopy was observed in 23.6%, 37%, 56.9% of patients who received 0.01%, 0.02% and 0.04 of netarsudil. In comparison, conjunctival hyperemia was experienced by 1.8 % of patients in the placebo arm. The level of conjunctival hyperemia experienced by patients in netarsudil 0.02% arm was markedly less than the levels which were reported in earlier trials. Majority of the conjunctival hyperemia was considered mild and no serious adverse events were reported. The data was reported from 215 patients of which 207 completed the study [53] [56] .
Netarsudil mesylate exhibited very low systemic exposure values when administered to healthy normotensive (12 to 21 mmHg) individuals in a phase I pharmacokinetics study. As a result, no drug-related effects on systemic safety parameters such as blood pressure and heart rate were observed. A total of 18 individuals in this study were administered once-daily netarsudil mesylate over eight days [60] .
Pharmacodynamics
Summary
Administration of netarsudil mesylate, once-daily via eye-drops, to an in vivo model of ocular hypertension resulted in a statistically significant reduction in episcleral venous pressure (EVP) and intra-ocular pressure (IOP) following the third daily dose. EVP and IOP were reduced by 35% and 39%, respectively, compared with baseline. Researchers estimated that up to 42% of the reduction in IOP was due to the effect of netarsudil mesylate on EVP [69] .
Results from the preclinical studies in the mouse model demonstrated that, administration of netarsudil reversed tissue stiffness and fibrosis in the trabecular meshwork (TM) caused by long term exposure to steroids in patients with primary open angle glaucoma. The reduction of stiffness was demonstrated directly using atomic force microscopy, as well as indirectly in live mice by measuring the movement of the TM in response to elevated intraocular pressure (IOP) [70] .
Antimicrobial Activity
Summary
Drug Interactions
Summary
Immunogenicity
Summary
Therapeutic Trials
Phase III
Treatment with qd netarsudil mesylate did not indicate non-inferiority of lowering of IOP, compared with bid timolol, at week 2, 6 and day 90, thus not meeting the defined primary endpoint in the phase III ROCKET 1 trial, in patients with glaucoma and ocular hypertension, with baseline IOPs above 20 to below 27 mmHg. Loss of efficacy was also seen at week 6 and day 90, in approximately 20% of patients. In patients with IOPs below 26 mmHg, netarsudil mesylate indicated non-inferiority, compared with timolol at the majority of the time points. In a pre-specified analysis, the drug indicated -inferiority to timolol and numerical superiority over timolol at all nine measured time points for patients with IOPs below 24 mmHg. The loss of efficacy in these patients was reduced to half for patients with IOPs less than 26 mmHg and these patients also indicated a decreased frequency of such an occurrence. ROCKET 1 randomised 182 patients to the netarsudil mesylate and 188 patients to the timolol cohort [46] .
According to 90-day topline data from the phase III ROCKET 4 trial, once-daily netarsudil mesylate (RhopressaTM) demonstrated non-inferiority compared with twice-daily timolol in patients with baseline IOPs ranging from above 20 to below 25 mmHg, thus meeting the study's primary efficacy endpoint. Netarsudil also demonstrated non-inferiority compared with timolol at the pre-specified secondary endpoint range of above 20 mmHg to below 27 mmHg, and also at a range of above 20 mmHg to below 28 mmHg. The drug candidate was consistent in lowering IOP levels across all baseline IOPs in the trial, and throughout the 90-day efficacy period. Six-month efficacy data for netarsudil mesylate showed a consistent level of IOP lowering across all baseline IOPs in the trial, and consistent IOP lowering throughout the six-month period. At months four, five and six netarsudil mesylate's performance remained within the non-inferiority range compared with timolol at each of the IOP measurement time points, including 8 a.m., 10 a.m. and 4 p.m. at baseline IOPs ranging from above 20 mmHg to below 25 mmHg and also from above 20 mmHg to below 27 mmHg. The phase III ROCKET 4 trial is compared the safety and efficacy of netarsudil mesylate with timolol maleate ophthalmic solution in 700 patients with open angle glaucoma or ocular hypertension in both eyes [30] [15] [31] .
Topline data of the randomised, single-masked, phase III trial in Japanese patients (n = 245) with primary open angle glaucoma or ocular hypertension showed that once daily netarsudil ophthalmic solution 0.02%, was superior to twice daily ripasudil hydrochloride hydrate ophthalmic solution 0.4%, in lowering intraocular pressure (IOP) at week four (p < 0.0001), the primary endpoint for the study. The baseline mean diurnal IOP was 20.5 and 20.8 millimeters of mercury (mmHg) in the netarsudil 0.02% and ripasudil 0.4% arm, respectively. At week four (primary endpoint), the mean diurnal IOP was statistically significantly lower (16.0 mmHg) in the netarsudil 0.02% group compared to the ripasudil 0.4% group (17.7 mmHg, p < 0.0001). At four weeks, netarsudil 0.02% reduced mean diurnal IOP by 4.7 mmHg (22.6%) from baseline, when compared with 3.0 mmHg (14.3%) with ripasudil 0.4% (p < 0.0001). Statistically significant IOP lowering with netarsudil was also observed at each of the study timepoints, 9 am, 11 am, and 4 pm at all study visits at weeks one, two and four (p < 0.01) [51] [50] .
Phase II
Once daily administration of netarsudil mesylate produced significant reductions in intraocular pressure (IOP) ranging from 5.7 mmHg to 6.2 mmHg in patients with elevated IOP during a phase IIb trial. The reduction in IOP values were consistent across all baseline IOP values measured in the trial. A total of 224 patients with open angle glaucoma or ocular hypertension were administered two different dose levels of netarsudil mesylate or latanoprost and assessed over 28-days [60] .
In a phase II trial in Japanese patients with open angle glaucoma and ocular hypertension, ophthalmic solution of netarsudil (0.01%, 0.02% and 0.04%) demonstrated statistically significant reduction in mean diurnal intraocular pressure (IOP) at day 29, with each concentration when compared with placebo (all p values < 0.0001). The mean diurnal IOP at week 1, week 2 and week 4 reduced by range of 4.1 to 4.6 mmHg, 4.4 to 4.8 mmHg and 4.8 to 5.1 mmHg for 0.01%, 0.02% and 0.04% of concentrations, respectively. Comparatively, placebo arm reduced mean diurnal IOP by a range of 1.4 to 1.7 mmHg. IOP lowering was consistent across the measurement period. The data was reported from 215 patients of which 207 completed the study [53] [56] .
Results from a phase II trial in patients with open-angle glaucoma and ocular hypertension showed that netarsudil mesylate ophthalmic solution (Rhopressa®) lowered the elevated intraocular pressure in patients by producing a statistically significant increase of approximately 35% over baseline in trabecular outflow facility. Results from this study is consistent with results of a study of similar design in healthy volunteers. The trial enrolled a total of 20 patients [82] [57] .
Top-line phase IIa data showed that netarsudil mesylate significantly reduced intraocular pressure (IOP) at all three doses tested (0.1%, 0.02% or 0.04% ophthalmic solution), compared with placebo, in patients with primary open-angle glaucoma or ocular hypertension. The peak efficacy was seen at least 8 hours after dosing and significant IOP reductions were maintained over 24 hours. Patients in the 0.02% cohort showed the greatest response during treatment, with a mean reduction in IOP of 6.9 mmHg and 5.9 mmHg at 8 hours and 24 hours post-dose, respectively. This double-blind trial randomised 80 patients to one of three doses of netarsudil mesylate, or vehicle alone, once-daily in the morning for 7 days [62] .
Netarsudil mesylate reduced the average diurnal IOP values of 18 normotensive individuals from 16 mmHg to 11mmHg after eight days of once-daily dosing, during a phase I pharmacokinetic study [60] .
Results from the phase II trial showed that lowered IOP in mean diurnal IOP by a range of 5.0 to 5.3 mmHg for pateints with an average baseline IOP of 18.3 mmHg was observed in patients treated with netarsudil ophthalmic solution 0.02%. The netarsudil ophthalmic solution 0.04% arm lowered IOP in mean diurnal IOP by a range of 5.2 mmHg to 6.6 mmHg for subjects with average baseline IOP of 20.2 mmHg. The placebo arm lowered IOP in mean diurnal IOP by a range of 2.0 to 2.5 mmHg for subjects with an average baseline pressure of 19.6 mmHg. Higher levels of IOP reduction to a statistically significant degree at day 28 as compared to placebo was demonstrated in both the netarsudil arms. The double-blind, randomised trial evaluated the safety and effectiveness of netarsudil 0.02% and 0.04% ophthalmic solution in comparison with placebo in Japanese/Japanese-American subjects with elevated intraocular pressure [58] [59] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 30 Nov 2020 | Trial Update | Aerie Pharmaceuticals plans a phase III trial for Ocular hypertension and Open-angle glaucoma (Ophthalmic) in Japan in November 2020 (NCT04620135) (700306181) [4] | 15 Apr 2022 |
| 15 Sep 2020 | Trial Update | Aerie Pharmaceuticals plans a phase II trial in Fuchs'-endothelial-dystrophy in USA (Ophthalmic) in September 2020 (NCT04498169) (700326245) | 19 Oct 2020 |
| 30 Jun 2020 | Regulatory Status | Aerie plans to hold a meeting with the regulatory authorities in Japan to discuss Phase III trial designs for netarsudil ophthalmic solution during the second quarter of 2020 [81] | 17 May 2020 |
| 31 Mar 2019 | Trial Update | Aerie Pharmaceuticals plans a phase II trial for Open angle glaucoma or Ocular hypertension in Japan in the March 2019 (NCT03844945) [58] | 20 Mar 2019 |
| 01 Dec 2018 | Regulatory Status | Aerie Pharmaceuticals intends to submit MAA to the European Medicines Agency for Netarsudil mesylate for Glaucoma or Ocular hypertension in the second half of 2018 [30] | 11 Oct 2018 |
| 30 Jun 2018 | Regulatory Status | Aerie Pharmaceuticals plans to launch Netarsudil mesylate in the mid-second quarter of 2018 [83] | 03 May 2018 |
| 28 Feb 2018 | Regulatory Status | The US FDA assigns PDUFA action date of 28 February 2018 for Netarsudil mesylate ophthalmic solution for Open-angle glaucoma and Ocular hypertension [85] | 22 Dec 2017 |
| 31 Oct 2017 | Trial Update | Aerie Pharmaceuticals plans a phase II trial for Open angle glaucoma and Ocular hypertension (Opthalmic) (NCT03233308) | 01 Aug 2018 |
| 31 Oct 2017 | Trial Update | Cornea Research Foundation of America plans a phase III trial for Ocular hypertension (Prevention) (NCT03248037) | 03 May 2018 |
| 31 Oct 2017 | Trial Update | Aerie Pharmaceuticals plans a phase II trial for Glaucoma or Ocular hypertension in USA in October 2017 (NCT03310580) | 22 Nov 2017 |
| 13 Oct 2017 | Regulatory Status | Aerie Pharmaceuticals announces a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee on October 13, 2017 to review the NDA for netarsudil ophthalmic solution 0.02% (Rhopressa™) for Open-angle glaucoma or Ocular hypertension [84] | 17 Oct 2017 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 20 Mar 2023 | Company Involvement | GrayBug inc. has merged with CalciMedica to form CalciMedica [3] Updated 22 Mar 2023 |
| 28 Feb 2023 | Phase Change - Marketed | Launched for Ocular hypertension in Sweden (Ophthalmic) (Santen Pharmaceutical pipeline, July 2023) Updated 13 Jul 2023 |
| 28 Feb 2023 | Phase Change - Marketed | Launched for Open-angle glaucoma in Sweden (Ophthalmic) (Santen Pharmaceutical pipeline, July 2023) Updated 13 Jul 2023 |
| 16 Feb 2023 | Phase Change - Registered | Registered for Ocular hypertension in Thailand (Ophthalmic) before February 2023 (Santen Pharmaceutical pipeline, February 2023) Updated 02 Mar 2023 |
| 16 Feb 2023 | Phase Change - Registered | Registered for Open-angle glaucoma in Thailand (Ophthalmic) before February 2023 (Santen Pharmaceutical pipeline, February 2023) Updated 02 Mar 2023 |
| 31 Jan 2023 | Phase Change - Registered | Registered for Ocular hypertension in Asia (Ophthalmic) (Santen Pharmaceutical pipeline; November 2023) Updated 27 Nov 2023 |
| 31 Jan 2023 | Phase Change - Registered | Registered for Open-angle glaucoma in Asia (Ophthalmic) (Santen Pharmaceutical pipeline; November 2023) Updated 27 Nov 2023 |
| 22 Nov 2022 | Company Involvement | Aerie Pharmaceuticals has been acquired and merged into Alcon Updated 16 Feb 2023 |
| 01 May 2022 | Phase Change - Preregistration | Preregistration for Ocular hypertension in Asia (Ophthalmic) (Santen Pharmaceutical pipeline, August 2022) Updated 25 Aug 2022 |
| 01 May 2022 | Phase Change - Preregistration | Preregistration for Open-angle glaucoma in Asia (Ophthalmic) (Santen Pharmaceutical pipeline, August 2022) Updated 25 Aug 2022 |
| 17 Mar 2022 | Trial Update | Aerie Pharmaceuticals withdrew clinical trial prior to enrolment due to COVID-19 related restrictions in Ocular hypertension and Open-angle glaucoma (Ophthalmic) (NCT04064918) Updated 15 Apr 2022 |
| 19 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 21 Jan 2022 |
| 31 Dec 2021 | Patent Information | Aerie Pharmaceuticals has patent protection for Latanoprost/netarsudil in the United States and internationally [6] Updated 01 Mar 2022 |
| 31 Dec 2021 | Patent Information | Aerie Pharmaceuticals files for patent protection for Latanoprost/netarsudil in the United States and internationally [6] Updated 01 Mar 2022 |
| 07 Dec 2021 | Licensing Status | Aerie Pharmaceuticals and Santen Pharmaceutical expands its existing license agreement for Netarsudil mesylate in Europe, Commonwealth of Independent States countries, China, India, parts of Latin America and the Oceania countries [4] Updated 10 Dec 2021 |
| 13 Oct 2021 | Scientific Update | Interim efficacy and adverse events data from a phase III trial in open-angle glaucoma and ocular hypertension released by Aerie Pharmaceuticals [51] Updated 14 Oct 2021 |
| 31 Aug 2021 | Trial Update | Aerie Pharmaceuticals completes phase III trial in Open-angle glaucoma and Ocular hypertension in Japan (Ophthalmic) in July 2021 (NCT04620135) Updated 06 Sep 2021 |
| 11 Aug 2021 | Trial Update | Aerie Pharmaceuticals completes a phase II trial in Fuchs' endothelial dystrophy in USA (Ophthalmic) (NCT04498169) Updated 13 Sep 2021 |
| 17 Jun 2021 | Trial Update | Aerie Pharmaceuticals completes enrolment in its phase III trial for Open-angle glaucoma and Ocular hypertension (Ophthalmic) in Japan [24] Updated 23 Jun 2021 |
| 10 May 2021 | Trial Update | Aerie Pharmaceuticals plans additional phase III trials for Ocular hypertension and Open angle glaucoma in Japan [1] [24] Updated 10 May 2021 |
| 05 May 2021 | Licensing Status | Netarsudil mesylate - Aerie Pharmaceuticals is available for licensing in Europe as of 05 May 2021. https://aeriepharma.com/ 9322582 Updated 10 May 2021 |
| 01 Apr 2021 | Scientific Update | Pharmacodynamics data from preclinical studies in Ocular hypertension released by Aerie [70] Updated 01 Apr 2021 |
| 12 Nov 2020 | Phase Change - III | Phase-III clinical trials in Ocular hypertension in Japan (Ophthalmic) (NCT04620135) Updated 16 Feb 2021 |
| 12 Nov 2020 | Phase Change - III | Phase-III clinical trials in Open-angle glaucoma in Japan (Ophthalmic) (NCT04620135) Updated 16 Feb 2021 |
| 28 Oct 2020 | Trial Update | Aerie Pharmaceuticals plans a phase III trial for Ocular hypertension and Open-angle glaucoma (Ophthalmic) in Japan in November 2020 (NCT04620135) [4] Updated 15 Apr 2022 |
| 28 Oct 2020 | Licensing Status | Netarsudil mesylate market licensed to Santen Pharmaceutical in Japan and several Asian countries [4] Updated 29 Oct 2020 |
| 17 Sep 2020 | Phase Change - II | Phase-II clinical trials in Fuchs' endothelial dystrophy in USA (Ophthalmic) (NCT04498169) Updated 19 Oct 2020 |
| 04 Aug 2020 | Trial Update | Aerie Pharmaceuticals plans a phase II trial in Fuchs'-endothelial-dystrophy in USA (Ophthalmic) in September 2020 (NCT04498169) Updated 19 Oct 2020 |
| 09 Apr 2020 | Regulatory Status | Aerie plans to hold a meeting with the regulatory authorities in Japan to discuss Phase III trial designs for netarsudil ophthalmic solution during the second quarter of 2020 [81] Updated 17 May 2020 |
| 20 Feb 2020 | Regulatory Status | Aerie Pharmaceuticals announces intention to launch netarsudil mesylate in Japan [25] Updated 25 Feb 2020 |
| 20 Feb 2020 | Trial Update | Aerie Pharmaceuticals plans a phase III trial in Japan Updated 25 Feb 2020 |
| 21 Nov 2019 | Phase Change - Registered | Registered for Ocular hypertension in Norway, Liechtenstein, Iceland, European Union (Ophthalmic) [21] Updated 29 Nov 2019 |
| 21 Nov 2019 | Phase Change - Registered | Registered for Open-angle glaucoma in Norway, Liechtenstein, Iceland, European Union (Ophthalmic) [21] Updated 29 Nov 2019 |
| 06 Nov 2019 | Licensing Status | Netarsudil mesylate - Aerie Pharmaceuticals is available for licensing in Japan as of 06 Nov 2019. https://aeriepharma.com/ 9279017 Updated 16 Nov 2019 |
| 06 Nov 2019 | Scientific Update | Efficacy and adverse events data from a phase II trial in Open angle glaucoma and Ocular hypertension released by Aerie Pharmaceuticals [53] Updated 14 Nov 2019 |
| 22 Sep 2019 | Regulatory Status | Committee for Medicinal Products for Human Use (CHMP) recommends approval of netarsudil netarsudil mesylate for Open angle glaucoma or Ocular hypertension in European Union [22] Updated 24 Sep 2019 |
| 19 Sep 2019 | Trial Update | Aerie Pharmaceuticals completes a phase II trial in Open angle glaucoma and Ocular hypertension in Japan (Ophthalmic) (NCT03844945) Updated 26 Nov 2019 |
| 10 Jul 2019 | Trial Update | Aerie Pharmaceuticals completes enrollment in a phase II trial in Open angle glaucoma and Ocular hypertension in Japan (Ophthalmic) (NCT03844945) Updated 10 Jul 2019 |
| 09 Jul 2019 | Trial Update | Cornea Research Foundation of America completes a phase III trial in Ocular hypertension (Prevention) in USA (Ophthalmic) (NCT03248037) Updated 11 Mar 2021 |
| 08 May 2019 | Trial Update | Aerie Pharmaceuticals plans phase III registration trials in Open angle glaucoma and Ocular hypertension in Japan Updated 10 May 2019 |
| 13 Mar 2019 | Trial Update | Aerie Pharmaceuticals initiates a phase II trial in Open angle glaucoma and Ocular hypertension in Japan (NCT03844945) Updated 20 Mar 2019 |
| 04 Jan 2019 | Trial Update | Aerie Pharmaceuticals plans a phase II trial for Open angle glaucoma or Ocular hypertension in Japan in the March 2019 (NCT03844945) [58] Updated 20 Mar 2019 |
| 25 Oct 2018 | Trial Update | Aerie Pharmaceuticals completes a phase II trial in Open angle glaucoma and Ocular hypertension in USA (Ophthalmic) (NCT03310580) Updated 14 Dec 2018 |
| 09 Oct 2018 | Phase Change - Preregistration | Preregistration for Ocular hypertension in European Union (Ophthalmic) before October 2018 [23] Updated 11 Oct 2018 |
| 09 Oct 2018 | Phase Change - Preregistration | Preregistration for Open angle glaucoma in European Union (Ophthalmic) before October 2018 [23] Updated 11 Oct 2018 |
| 09 Oct 2018 | Regulatory Status | The European Medicines Agency accepts MAA for netarsudil mesylate for Open angle glaucoma or Ocular hypertension for review [23] Updated 11 Oct 2018 |
| 15 Aug 2018 | Scientific Update | Efficacy data from a phase II trial in Open angle glaucoma and Ocular Hypertension released by Aerie Pharmaceuticals [82] Updated 22 Aug 2018 |
| 08 May 2018 | Regulatory Status | Aerie Pharmaceuticals plans a regulatory submission in Japan Updated 14 May 2018 |
| 30 Apr 2018 | Phase Change - Marketed | Launched for Ocular hypertension in USA (Ophthalmic) [8] Updated 03 May 2018 |
| 30 Apr 2018 | Phase Change - Marketed | Launched for Open angle glaucoma in USA (Ophthalmic) [8] Updated 03 May 2018 |
| 19 Apr 2018 | Trial Update | Aerie Pharmaceuticals completes a phase II trial for Open angle glaucoma and Ocular Hypertension in USA (Ophthalmic) (NCT03233308) Updated 10 Jul 2018 |
| 01 Mar 2018 | Phase Change - II | Phase-II clinical trials in Open angle glaucoma and Ocular hypertension in Japan (Ophthalmic) Updated 22 Mar 2018 |
| 01 Mar 2018 | Trial Update | Aerie Pharmaceuticals plans phase III registration trials for Open angle glaucoma and Ocular hypertension in Japan (Ophthalmic) Updated 22 Mar 2018 |
| 20 Feb 2018 | Regulatory Status | Aerie Pharmaceuticals plans to launch Netarsudil mesylate in the mid-second quarter of 2018 [83] Updated 03 May 2018 |
| 21 Dec 2017 | Phase Change - No development reported(Preclinical) | No development reported - Preclinical for Neurological disorders in USA (unspecified route) Updated 21 Dec 2017 |
| 18 Dec 2017 | Phase Change - Registered | Registered for Ocular hypertension in USA (Ophthalmic) - First global approval [9] Updated 20 Dec 2017 |
| 18 Dec 2017 | Phase Change - Registered | Registered for Open-angle glaucoma in USA (Ophthalmic) - First global approval [9] Updated 20 Dec 2017 |
| 17 Nov 2017 | Trial Update | Aerie Pharmaceuticals initiates enrolment a phase II trial in Glaucoma and Ocular hypertension in USA [27] (NCT03310580) Updated 22 Nov 2017 |
| 17 Nov 2017 | Trial Update | Aerie Pharmaceuticals plans phase III trials in Glaucoma and Ocular hypertension in Japan [27] Updated 22 Nov 2017 |
| 08 Nov 2017 | Regulatory Status | Aerie Pharmaceuticals plans a regulatory filing in Japan Updated 13 Nov 2017 |
| 20 Oct 2017 | Trial Update | Aerie Pharmaceuticals initiates enrolment in a phase II trial for Open angle glaucoma and Ocular Hypertension in USA (Ophthalmic) (NCT03233308) Updated 11 Dec 2017 |
| 20 Oct 2017 | Trial Update | Aerie Pharmaceuticals plans a phase II trial for Glaucoma or Ocular hypertension in USA in October 2017 (NCT03310580) Updated 22 Nov 2017 |
| 13 Oct 2017 | Regulatory Status | The Dermatologic and Ophthalmic Drugs Advisory Committee of the US FDA votes in favour of netarsudil ophthalmic solution 0.02% (Rhopressa™) for Open-angle glaucoma or Ocular hypertension [11] Updated 17 Oct 2017 |
| 20 Sep 2017 | Regulatory Status | Aerie Pharmaceuticals announces a meeting with the Dermatologic and Ophthalmic Drugs Advisory Committee on October 13, 2017 to review the NDA for netarsudil ophthalmic solution 0.02% (Rhopressa™) for Open-angle glaucoma or Ocular hypertension [84] Updated 17 Oct 2017 |
| 05 Sep 2017 | Phase Change - III | Phase-III clinical trials in Ocular hypertension (Prevention) in USA (Ophthalmic) (NCT03248037) Updated 03 May 2018 |
| 16 Aug 2017 | Trial Update | Cornea Research Foundation of America plans a phase III trial for Ocular hypertension (Prevention) (NCT03248037) Updated 03 May 2018 |
| 12 Jul 2017 | Trial Update | Aerie Pharmaceuticals plans a phase II trial for Open angle glaucoma and Ocular hypertension (Opthalmic) (NCT03233308) Updated 01 Aug 2018 |
| 16 May 2017 | Regulatory Status | The US FDA assigns PDUFA action date of 28 February 2018 for Netarsudil mesylate ophthalmic solution for Open-angle glaucoma and Ocular hypertension [85] Updated 22 Dec 2017 |
| 15 May 2017 | Regulatory Status | US FDA completes 60–day review of netarsudil mesylate NDA [12] Updated 18 May 2017 |
| 12 Apr 2017 | Regulatory Status | Aerie Pharmaceuticals intends to submit MAA to the European Medicines Agency for Netarsudil mesylate for Glaucoma or Ocular hypertension in the second half of 2018 [30] Updated 11 Oct 2018 |
| 12 Apr 2017 | Scientific Update | Positive six-month topline efficacy and adverse events data from the phase III ROCKET 4 trial in Glaucoma and Ocular hypertension released by Aerie Pharmaceuticals [30] Updated 20 Apr 2017 |
| 28 Feb 2017 | Regulatory Status | Aerie Pharmaceuticals resubmits NDA to the US FDA for netarsudil mesylate for Open-angle glaucoma and Ocular hypertension [13] Updated 09 Mar 2017 |
| 28 Feb 2017 | Phase Change - Preregistration | Preregistration for Ocular hypertension in USA (Ophthalmic) [17] Updated 03 Mar 2017 |
| 28 Feb 2017 | Phase Change - Preregistration | Preregistration for Open-angle glaucoma in USA (Ophthalmic) [17] Updated 03 Mar 2017 |
| 23 Dec 2016 | Regulatory Status | Aerie Pharmaceuticals plans to resubmit NDA to the US FDA for Netarsudil mesylate for Open-angle glaucoma and Ocular hypertension, at the end of the first quarter of 2017 [14] Updated 29 Dec 2016 |
| 01 Dec 2016 | Trial Update | Aerie Pharmaceuticals completes the pivotal phase III ROCKET 4 trial in Glaucoma and Ocular hypertension in USA (0.02% Ophthalmic) (NCT02558374) Updated 20 Apr 2017 |
| 01 Dec 2016 | Trial Update | Aerie Pharmaceuticals completes the pivotal phase III ROCKET 3 trial in Glaucoma and Ocular hypertension in Canada (Ophthalmic) (NCT02246764) Updated 20 Apr 2017 |
| 02 Nov 2016 | Trial Update | Aerie Pharmaceutical completes a phase II trial in Glaucoma and Ocular hypertension in USA (NCT02874846) Updated 07 Nov 2016 |
| 27 Oct 2016 | Phase Change - Preregistration-Submission Withdrawal | Regulatory submission withdrawn for Ocular hypertension in USA (Ophthalmic) [15] Updated 02 Nov 2016 |
| 27 Oct 2016 | Phase Change - Preregistration-Submission Withdrawal | Regulatory submission withdrawn for Open-angle glaucoma in USA (Ophthalmic) [15] Updated 02 Nov 2016 |
| 27 Oct 2016 | Regulatory Status | Aerie Pharmaceuticals plans to resubmit NDA to the US FDA for Netarsudil mesylate for Open-angle glaucoma and Ocular hypertension, in January 2017 [15] Updated 02 Nov 2016 |
| 27 Oct 2016 | Scientific Update | Positive 90-day topline efficacy and adverse events data from the phase III ROCKET 4 trial in Glaucoma and Ocular hypertension released by Aerie Pharmaceuticals [15] Updated 02 Nov 2016 |
| 06 Sep 2016 | Phase Change - Preregistration | Preregistration for Ocular hypertension and Glaucoma in USA (Ophthalmic, 0.02%) [16] Updated 07 Sep 2016 |
| 16 Jun 2016 | Trial Update | Aerie Pharmaceuticals completes enrolment in a phase III trial for Glaucoma and Ocular Hypertension in USA [28] Updated 17 Jun 2016 |
| 30 Apr 2016 | Trial Update | Aerie Pharmaceuticals completes a phase I trial in Healthy volunteers in USA (NCT02406287) Updated 30 May 2016 |
| 01 Mar 2016 | Trial Update | Aerie Pharmaceuticals completes the phase III Rocket 2 trial for Glaucoma or Ocular hypertension in USA (NCT02207621) Updated 18 Jul 2016 |
| 23 Sep 2015 | Trial Update | Aerie Pharmaceuticals initiates the phase III Rocket 4 trial for Glaucoma or Ocular hypertension in USA [29] Updated 27 Sep 2015 |
| 18 Sep 2015 | Scientific Update | Interim adverse events data from a phase III Rocket 2 trial in Glaucoma released by Aerie [19] Updated 18 Sep 2015 |
| 16 Sep 2015 | Regulatory Status | Aerie intends to submit NDA to the US FDA in mid-2016 and commercialise the product in 2017 [19] Updated 06 Oct 2015 |
| 16 Sep 2015 | Phase Change - Preclinical | Preclinical trials in Neurological disorders in USA (unspecified route) Updated 30 Sep 2015 |
| 01 Sep 2015 | Trial Update | Aerie Pharmaceuticals initiates enrolment in a phase III trial for Glaucoma and Ocular Hypertension in USA (NCT02558374) Updated 01 Oct 2015 |
| 13 Aug 2015 | Trial Update | Aerie Pharmaceuticals plans the phase III Rocket 4 trial in Glaucoma and Ocular hypertension [38] Updated 13 Aug 2015 |
| 05 Aug 2015 | Licensing Status | Aerie and GrayBug agree to co-develop sustained-release AR 13324 for eye disorders [7] Updated 14 Aug 2015 |
| 28 Apr 2015 | Trial Update | Aerie Pharmaceuticals completes the phase III ROCKET 1 trial in Glaucoma or Ocular hypertension in USA (NCT02207491; 9178162) before April 2015 Updated 02 May 2015 |
| 23 Apr 2015 | Scientific Update | Efficacy and adverse events data from the phase III ROCKET 1 trial in Glaucoma and Ocular hypertension released by Aerie Pharmaceuticals [46] Updated 06 May 2015 |
| 08 Apr 2015 | Trial Update | Aerie Pharmaceuticals plans a phase I trial in Healthy volunteers in USA (NCT02406287) Updated 08 Apr 2015 |
| 01 Apr 2015 | Trial Update | Aerie Pharmaceuticals initiates a phase I trial in Healthy volunteers in USA (NCT02406287) Updated 02 May 2015 |
| 24 Mar 2015 | Trial Update | Aerie Pharmaceuticals completes enrolment in the phase III Rocket 2 trial for Glaucoma or Ocular hypertension in USA [42] (NCT02207621) Updated 26 Mar 2015 |
| 27 Feb 2015 | Patent Information | Aerie Pharmaceuticals has patent protection for AR 13324 in USA (Aerie Pharmaceuticals 10-K, February 2015) Updated 26 Oct 2015 |
| 02 Dec 2014 | Trial Update | Aerie Pharmaceuticals completes enrolment in the phase III Rocket 1 trial for Glaucoma or Ocular hypertension in USA [41] (NCT02207491) Updated 04 Dec 2014 |
| 29 Aug 2014 | Phase Change - III | Phase-III clinical trials in Glaucoma in Canada (Ophthalmic) Updated 04 Sep 2014 |
| 29 Aug 2014 | Phase Change - III | Phase-III clinical trials in Ocular hypertension in Canada (Ophthalmic) Updated 04 Sep 2014 |
| 29 Jul 2014 | Licensing Status | AR 13324 is available for licensing in Europe, Japan and other territories as of 24 Jul 2014 [34] . Updated 29 Jul 2014 |
| 14 Jul 2014 | Phase Change - III | Phase-III clinical trials in Glaucoma in USA (Ophthalmic) Updated 18 Jul 2014 |
| 14 Jul 2014 | Phase Change - III | Phase-III clinical trials in Ocular hypertension in USA (Ophthalmic) Updated 18 Jul 2014 |
| 26 Feb 2014 | Scientific Update | Pharmacodynamics data from a preclinical trial in Ocular hypertension released by Aerie Pharmaceuticals [69] Updated 27 Feb 2014 |
| 10 Jan 2014 | Scientific Update | Efficacy data from a phase IIb trial and efficacy/safety data from a phase I trial in Ocular hypertension released by Aerie Pharmaceuticals [60] Updated 14 Jan 2014 |
| 01 Jun 2013 | Trial Update | Aerie Pharmaceuticals completes a phase IIb trial in Glaucoma & Ocular hypertension in USA (NCT01731002) Updated 18 Jun 2013 |
| 22 Jan 2013 | Trial Update | Aerie Pharmaceuticals completes enrolment in its phase IIb trial for Glaucoma & Ocular hypertension in USA (NCT01731002) Updated 04 Feb 2013 |
| 20 Nov 2012 | Trial Update | Aerie Pharmaceuticals initiates enrolment in a phase IIb trial for Glaucoma & Ocular hypertension in USA (NCT01731002) Updated 07 Dec 2012 |
| 02 Nov 2012 | Scientific Update | Final efficacy and adverse events data from a phase IIa trial in Glaucoma released by Aerie Pharmaceuticals [62] Updated 06 Nov 2012 |
| 19 Jul 2012 | Trial Update | Aerie Pharmaceutical completes a phase IIa trial in Glaucoma in USA (NCT01528787) Updated 06 Nov 2012 |
| 03 Apr 2012 | Phase Change - II | Phase-II clinical trials in Ocular hypertension in USA (Ophthalmic) Updated 07 Dec 2012 |
| 03 Apr 2012 | Phase Change - II | Phase-II clinical trials in Glaucoma in USA (Ophthalmic) Updated 06 Nov 2012 |
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Aerie Pharmaceuticals Completes Enrollment of Rocket 4 Phase 3 Clinical Trial of Rhopressa(TM) (netarsudil ophthalmic solution) 0.02%.
Media Release -
Aerie Pharmaceuticals Initiates Fourth Phase 3 Clinical Trial of RhopressaTM.
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Aerie Pharmaceuticals Reports Positive Rocket 4 Six-Month Topline Safety and Efficacy Results for RhopressaTM (netarsudil ophthalmic solution) 0.02%.
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A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
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Aerie Pharmaceuticals Receives Positive Feedback from FDA.
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Aerie Pharmaceuticals Inc. Initiates Phase 3 Safety-Only Registration Trial in Canada of RhopressaTM in Patients with Glaucoma.
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Aerie Pharmaceuticals, Inc. Receives Health Canada No Objection Letter to Commence Phase 3 Registration Trial of RhopressaTM in Patients with Glaucoma in Canada.
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Aerie Pharmaceuticals Initiates Phase 3 Registration Trials of RhopressaTM, Novel Triple-Action Product to Lower Intraocular Pressure in Patients with Glaucoma.
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A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety of AR-13324 Ophthalmic Solution, 0.02% QD & BID Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
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Aerie Pharmaceuticals Announces that Richard A. Lewis, M.D., Has Joined as Chief Medical Officer.
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Aerie Pharmaceuticals Reports Second Quarter 2015 Financial Results and Provides Business Update.
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Aerie Pharmaceuticals Reports Third Quarter 2013 Financial Results and Provides Business and Product Development Update.
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Aerie Pharmaceuticals Reports Third Quarter 2014 Financial Results and Provides Business and Product Development Update.
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Aerie Pharmaceuticals Completes Enrollment in Phase 3 Registration Trial (Rocket 1) of Rhopressa(Tm), Novel Triple-Action Product to Lower Intraocular Pressure in Patients with Glaucoma.
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Aerie Pharmaceuticals Completes Enrollment in Second Phase 3 Registration Trial (Rocket 2) of Rhopressa(Tm), Novel Triple-Action Product to Lower Intraocular Pressure in Patients with Glaucoma.
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A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% q.d. and b.i.d. Compared to Timolol Maleate Ophthalmic Solution, 0.5% b.i.d. in Patients With Elevated Intraocular Pressure
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Aerie Pharmaceuticals Reports Positive RhopressaTM QD (netarsudil ophthalmic solution) 0.02% 12 Month Interim Safety Results for Rocket 2.
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Aerie Pharmaceuticals Reports First Quarter 2015 Financial Results and Provides Business and Strategic Update.
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Aerie Pharmaceuticals Reports Initial RhopressaTM Phase 3 Efficacy Results.
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Aerie Pharmaceuticals to Announce First Quarter 2015 Financial Results and Host Conference Call on Thursday, May 7, 2015.
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Aerie Pharmaceuticals Announces Acceleration of Expected Timeline for Reporting Efficacy Results from Phase 3 Registration Trial (Rocket 1) of RhopressaTM.
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A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-13324 Ophthalmic Solution, 0.02% Compared to Timolol Maleate Ophthalmic Solution, 0.5% in Patients With Elevated Intraocular Pressure
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A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
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Aerie Pharmaceuticals Announces Positive Phase 3 Topline Results for Netarsudil Ophthalmic Solution 0.02% Clinical Trial in Japan.
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A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
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Aerie Pharmaceuticals Announces Positive Topline Results for Netarsudil Ophthalmic Solution in Phase 2 Study Conducted in Japan.
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Aerie Pharmaceuticals Completes Enrollment of the Netarsudil Ophthalmic Solution Phase 2 Clinical Trial in Japan Months Ahead of Schedule.
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Aerie Pharmaceuticals Initiates Netarsudil Ophthalmic Solution Phase 2 Clinical Trial in Japan Designed to Support Requirements for Future Regulatory Filing.
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A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety, Ocular Hypotensive Efficacy and Optimum Dose Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
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A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure
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Aerie Pharmaceuticals Announces Positive Topline Results of Netarsudil Ophthalmic Solution in Pilot Phase 2 Study Supporting Clinical Development in Japa.
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A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States
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Aerie Pharmaceuticals Reports Positive Results for Lead Candidate AR-13324 in Normotensive Individuals.
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A Phase 2, Double-masked, Randomized, Multi-center, Active-controlled, Dose-response Parallel-group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
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Aerie Pharmaceuticals Announces Positive Phase 2a Clinical Results for its Novel, Dual Mechanism Compound, AR-13324, for the Treatment of Glaucoma.
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A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of Three Doses of AR-13324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
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Aerie Pharmaceuticals Reports Third Quarter 2016 Financial Results and Provides Business Update.
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A Double-masked, Randomized, Placebo-controlled Study of the Nocturnal and Diurnal IOP-lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-hour Period.
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An Open-label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of AR-13324 Ophthalmic Solution, 0.02% in Healthy Volunteers
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A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers
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Aerie Pharmaceuticals Announces Potential Breakthroughs with New Preclinical Research.
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Aerie Pharmaceuticals Announces Study Results Supporting Additional Mechanism of Action for Lead Glaucoma Drug Candidate AR-13324.
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Aerie Pharmaceuticals Announces Publication of Peer-Reviewed Paper Evaluating the Treatment Effect of Netarsudil on Outflow Function in Steroid-Induced Glaucoma .
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Aerie Pharmaceuticals Announces Pricing of Public Offering of Common Stock.
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Aerie Pharmaceuticals Announces Public Offering of Common Stock-23 Jan-2018.
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Aerie Pharmaceuticals Raises $125 Million in ATM Sales and Upsized Follow-On Offering.
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Aerie Pharmaceuticals Announces Public Offering of Common Stock 25-may.
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Aerie Pharmaceuticals Raises $125 Million in Public Offerings.
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Aerie Pharmaceuticals Announces Public Offering of Common Stock.
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Aerie Announces Closing of $125 Million Convertible Notes Financing.
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Aerie Pharmaceuticals Completes $30 Million Series B Financing to Fund Further Development of Innovative Glaucoma Product Portfolio.
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Aerie Pharmaceuticals Announces $21 Million Series A Financing; Company to Develop Innovative Products for Treatment of Glaucoma.
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Aerie Pharmaceuticals Initiates Phase 2b Study of PG324, a Novel Fixed-Combination Product to Treat Patients with Glaucoma or Ocular Hypertension.
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Aerie Pharmaceuticals Provides 2020 Company and Guidance Update Associated with COVID-19.
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Aerie Pharmaceuticals Reports Topline Result from Rhopressa(R) Mechanism of Action Study.
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Aerie Pharmaceuticals Announces Appointment of John LaRocca as General Counsel.
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Aerie Pharmaceuticals Announces FDA Advisory Committee Meeting for Rhopressa(T) (netarsudil ophthalmic solution) 0.02%.
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Aerie Pharmaceuticals Announces New Hires.
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Aerie Pharmaceuticals Reports Third Quarter 2019 Financial Results, Updates Full-Year 2019 Guidance and Provides Business Update.
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