Aerie Pharmaceuticals, Inc. (AERI) Receives Health Canada "No Objection Letter" To Commence Phase 3 Registration Trial Of Rhopressatm In Patients With Glaucoma In Canada
7/24/2014 1:02:16 PM
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 it has received a No Objection Letter (“NOL”) from Health Canada to conduct a Phase 3 registration trial 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 in Canada. The study, named “Rocket 3,” is designed to evaluate safety and tolerability of RhopressaTM in patients over 12 months and is part of a broad Phase 3 program being conducted by Aerie. The Company recently announced the commencement of two Phase 3 trials in the United States, “Rocket 1” and “Rocket 2,” which are focused on demonstrating non-inferiority of IOP lowering for RhopressaTM compared to timolol, the most widely used comparator in registration trials for glaucoma. Aerie anticipates total enrollment of approximately 1,300 patients in the three Phase 3 trials of RhopressaTM.
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