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
Phase of Trial: Phase III
Latest Information Update: 20 Sep 2017
At a glance
- Drugs Netarsudil (Primary) ; Timolol
- Indications Glaucoma; Ocular hypertension
- Focus Registrational; Therapeutic Use
- Acronyms Rocket 1
- Sponsors Aerie Pharmaceuticals
- 20 Sep 2017 According to an Aerie Pharmaceuticals media release, a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled with the company for October 13, 2017 to review the NDA for Rhopressa (netarsudil ophthalmic solution) 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension.
- 15 May 2017 According to an Aerie Pharmaceuticals media release, the company has received notification from U.S. Food and Drug Administration (FDA) that the FDA has completed its initial 60 day review of the RhopressaTM NDA (new drug application) and determined that the application is sufficiently complete to permit a substantive review. The FDA has set the PDUFA goal date for the completion of the FDA's review of the RhopressaTM NDA for February 28, 2018.
- 01 Mar 2017 According to an Aerie Pharmaceuticals media release, on February 28, 2017 the company has resubmitted its NDA (New Drug Application) for Rhopressa to the FDA after notification by its contract drug product manufacturer that the vendor's Tampa, Florida facility is now ready for pre-approval inspection by the FDA for Rhopressa.