Aerie Pharmaceuticals has begun patient dosing in a phase 3 European trial of Roclatan for lowering IOP in patients with open-angle glaucoma or ocular hypertension, according to a company press release.
Roclatan (netarsudil 0.02%/latanoprost 0.005% ophthalmic solution) is a once-daily eye drop. The two-arm, 6-month Mercury 3 safety trial will enroll approximately 500 patients and provide a 90-day interim efficacy readout comparing the fixed-dose combination therapy to Ganfort (bimatoprost/timolol, Allergan), the release said.
The trial, conducted primarily in the United Kingdom, France, Germany, Italy, Spain and Belgium, will help with regulatory approval and commercialization in Europe and is not needed for U.S. approval.
The company expects to begin a Rhopressa (netarsudil ophthalmic solution 0.02%) clinical program for the Japanese market later this year, according to Vicente Anido Jr., PhD, chairman and CEO of Aerie.