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July 14, 2014
06:44 EDTAERIAerie Pharmaceuticals initiates Phase 3 trials of Rhopressa
Aerie Pharmaceuticals announced that on July 11, dosing commenced of the first patients enrolled in the Phase 3 registration clinical trials of Rhopressa, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure in patients with glaucoma or ocular hypertension. Aerie anticipates total enrollment of approximately 1,300 patients in three Phase 3 registration trials of Rhopressa. 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 Rhopressa compared to timolol. 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.” Pending success of the studies and regulatory approval, Aerie expects RhopressaTM to compete against PGA products as an initial therapy for patients with IOPs of 26 mmHg or below at the time of diagnosis, which represents the significant majority of patients with glaucoma and ocular hypertension. Additionally, the company believes Rhopressa may be used as the add-on product of choice for patients on PGA therapy requiring further IOP lowering, due to its strong and consistent IOP-lowering effect, once-daily dosing and ability to target the trabecular meshwork.
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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."

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