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Dosing has commenced for the first patients enrolled in Aerie Pharmaceuticals’ phase III registration trial in Canada of Rhopressa, a novel once-daily, triple-action eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension.
Bedminister, NJ-Dosing has commenced for the first patients enrolled in Aerie Pharmaceuticals’ phase III registration trial in Canada of Rhopressa, a novel once-daily, triple-action eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension.
The study, named “Rocket 3,” is designed to evaluate safety and tolerability of the eye drop in patients over a 12-month period, and is part of a broad phase III program being conducted by Aerie.
The company recently announced the commencement of two phase III trials in the United States: “Rocket 1” and “Rocket 2,” which are focused on demonstrating non-inferiority of IOP lowering for the eye drops compared with timolol.
Aerie said it anticipates total enrollment of approximately 1,300 patients in the three phase III trials of the eye drops.
“Our . . . study in Canada is the third and final trial to commence in our phase III program, which continues to show strong momentum and interest from the ophthalmology community,” said Vicente Anido Jr., PhD, chairman and chief executive officer at Aerie. “This trial will supplement the safety studies required to file our new drug application (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,” he continued. “As previously announced, we anticipate top-line 3-month efficacy results from the phase III program in mid-2015 based on current timelines, with a potential NDA filing by mid-2016.”â¨
Pending progress of the phase III program and regulatory approvals, Aerie said it intends to commercialize the eye drops 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.
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