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Aerie announces phase 3 registration trial of Rhopressa in Canada
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Aerie Pharmaceuticals announced it recently initiated a phase 3 registration trial of Rhopressa, a once-daily, triple-action eye drop designed to lower IOP in patients with glaucoma or ocular hypertension, according to a company press release.
The study, Rocket 3, will evaluate safety and tolerability of Rhopressa during a 12-month period.
Two additional phase 3 studies, Rocket 1 and Rocket 2, were launched previously in the U.S. with the aim of demonstrating non-inferiority of Rhopressa in lowering IOP compared with timolol. Aerie plans to enroll 1,300 patients in the phase 3 trials, according to the release.
“This trial will supplement the safety studies required to file our [New Drug Application] in the United States, and potentially result in sufficient data for submission to the European regulatory authorities for product approval in Europe,” Vicente Anido, Jr., PhD, chairman and CEO of Aerie, said in the release.
The company anticipates top-line 3-month results from the phase 3 trials by mid-2015, with potential NDA filing by mid-2016.
With the pending progress and regulatory approvals of Rhopressa, Aerie will commercialize the product in North America and will also seek commercialization partners in other countries, according to the release.