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February 25, 2014
06:36 EDTAERIAerie Pharmaceuticals reports positive results from AR-13324 study
Aerie Pharmaceuticals announced the results of preclinical in vivo research demonstrating the ability of AR-13324 to reduce episcleral venous pressure, or EVP, in the eye. AR-13324 previously has been shown to lower intraocular pressure, or IOP, by increasing fluid outflow through the trabecular pathway, the eye's primary drain, and by reducing the production of fluid in the eye. The present study affirmed the hypothesis that AR-13324 also can lower IOP through a third mechanism of action, the reduction of EVP. This may represent a breakthrough in the lowering of IOP in patients with glaucoma and ocular hypertension.
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July 24, 2014
07:33 EDTAERIAerie receives NOL for Rhopressa Phase 3 registration trial
Aerie Pharmaceuticals announced that it has received a No Objection Letter from Health Canada to conduct a Phase 3 registration trial of Rhopressa. The study, named “Rocket 3,” is designed to evaluate safety and tolerability of Rhopressa 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 U.S., “Rocket 1” and “Rocket 2,” which are focused on demonstrating non-inferiority of IOP lowering for Rhopressa 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 Rhopressa. The company said, " Pending progress of the program and regulatory approvals, Aerie intends to commercialize Rhopressa in North American markets with its own sales force and will seek commercialization partners in other key territories, including Europe and Japan. Aerie fully owns its product candidates, has no licenses, and has patent protection for both use and composition of matter through 2030."
July 14, 2014
07:37 EDTAERIAerie initiates Rhopressa Phase 3 registration trials
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06:44 EDTAERIAerie Pharmaceuticals initiates Phase 3 trials of Rhopressa
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