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A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure

Trial Profile

A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2019

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At a glance

  • Drugs Latanoprost/netarsudil (Primary) ; Latanoprost; Netarsudil
  • Indications Ocular hypertension; Open-angle glaucoma
  • Focus Registrational; Therapeutic Use
  • Acronyms Mercury 1
  • Sponsors Aerie Pharmaceuticals
  • Most Recent Events

    • 12 Mar 2019 According to an Aerie Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.This approval is based on the data from MERCURY 1 and MERCURY 2 trials.
    • 23 Jul 2018 According to an Aerie Pharmaceuticals media release, company received Early the Day 74 notification from the U.S. Food and Drug Administration (FDA) earlier than scheduled, the FDA has completed its initial 60-day review of the NDA (new drug application) for Roclatan with PDUFA Date Set for March 14, 2019.
    • 15 May 2018 According to an Aerie Pharmaceuticals media release, Company has submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Roclatan.
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