Aerie Pharmaceuticals, Inc. (AERI) Initiates Phase 3 Registration Trials of Rhopressa, Novel Triple-Action Product To Lower Intraocular Pressure In Patients With Glaucoma
7/15/2014 11:21:49 AM
BEDMINSTER, N.J. & RESEARCH TRIANGLE PARK, N.C. & NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced that on July 11, dosing commenced of the first patients enrolled in the Company’s Phase 3 registration clinical trials of RhopressaTM, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Aerie anticipates total enrollment of approximately 1,300 patients in three Phase 3 registration trials of RhopressaTM. The trials will measure efficacy over three months and safety over 12 months. The primary efficacy endpoint of the trials will be to demonstrate non-inferiority of IOP lowering for RhopressaTM compared to timolol. Timolol is the most widely used comparator in registration trials for glaucoma. There will be two trials conducted in the United States, named “Rocket 1” and “Rocket 2,” and one safety-only study in Canada, named “Rocket 3.”
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