Evaluation of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma and Ocular Hypertension
Phase of Trial: Phase III
Latest Information Update: 13 Oct 2017
At a glance
- Drugs Netarsudil (Primary) ; Timolol
- Indications Glaucoma; Ocular hypertension
- Focus Registrational; Therapeutic Use
- Acronyms Rocket 2
- Sponsors Aerie Pharmaceuticals
- 13 Oct 2017 According to an Aerie Pharmaceuticals media release, the Dermatologic and Ophthalmic Drugs Advisory Committee of the US FDA has voted in favor of Rhopressa™ (netarsudil ophthalmic solution) 0.02%.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History