Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension.
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 4
- 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.
- 12 Apr 2017 Status changed from active, no longer recruiting to completed, according to an Aerie Pharmaceuticals media release.
- 12 Apr 2017 According to an Aerie Pharmaceuticals media release, this study will provide six-month safety data adequate for regulatory filing in Europe and is not required for U.S. FDA approval. The European regulatory filing for Rhopressa is currently expected to take place in the second half of 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History