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

Trial Profile

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

Completed
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 1
  • Sponsors Aerie Pharmaceuticals
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top