Aerie Pharmaceuticals Inc.
Bedminster, N.J. & Research Triangle Park, N.C. & Newport Beach, Calif. -- Aerie Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced that on August 29, dosing commenced of the first patients enrolled in the Company’s Phase 3 registration trial in Canada 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. The study, named “Rocket 3,” is designed to evaluate safety and tolerability of RhopressaTM in patients over a 12 month period 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.
“Our RhopressaTM study in Canada is the third and final trial to commence in our Phase 3 program, which continues to show strong momentum and interest from the ophthalmology community. This trial will supplement the safety studies required to file our NDA in the United States, and potentially result in sufficient safety data for submission to the European regulatory authorities for product approval in Europe. Further, it establishes our name and presence in Canada, which could become an important market for Aerie in the future,” stated Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “As previously announced, we anticipate top-line three-month efficacy results from the RhopressaTM Phase 3 program in mid-2015 based on current timelines, with a potential NDA filing by mid-2016.”
Pending progress of the RhopressaTM Phase 3 program and regulatory approvals, Aerie intends to commercialize RhopressaTM in North American markets with its own sales force and will seek commercialization partners in other key territories, including Japan and possibly Europe. Aerie fully owns its product candidates, has no licenses, and has patent protection for both use and composition of matter through 2030.