Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension
Phase of Trial: Phase III
Latest Information Update: 15 May 2017
At a glance
- Drugs Netarsudil (Primary) ; Timolol
- Indications Glaucoma; Ocular hypertension
- Focus Registrational; Therapeutic Use
- Acronyms Rocket 2
- Sponsors Aerie Pharmaceuticals
- 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.
- 23 Dec 2016 According to an Aerie Pharmaceuticals media release, the company expects to resubmit the Rhopressa NDA filing near the end of the first quarter of 2017 after receiving notification from the contract drug product manufacturer that the manufacturing line related to the product is inspection ready.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History