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Aerie Pharmaceuticals Completes Enrollment of its first Phase 3 Clinical Trial of Netarsudil Ophthalmic Solution in Japan


Benzinga | Jun 17, 2021 06:30AM EDT

Aerie Pharmaceuticals Completes Enrollment of its first Phase 3 Clinical Trial of Netarsudil Ophthalmic Solution in Japan

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today announced the completion of patient enrollment for its first Phase 3 clinical trial of netarsudil ophthalmic solution in Japan, comparing netarsudil ophthalmic solution 0.02% ("netarsudil"), administered once a day in the evening, to ripasudil hydrochloride hydrate ophthalmic solution 0.4% ("ripasudil"), marketed as Glanatec(r) in Japan, administered twice a day, in the morning and evening.

The first patient to enter this randomized, single-masked, multi-center, parallel-group Phase 3 study was dosed in early December 2020. A total of 245 patients were successfully randomized across the netarsudil and ripasudil treatment arms. The netarsudil arm includes a netarsudil drop in the evening and netarsudil ophthalmic solution vehicle administered in the morning to preserve the masking of the trial. The ripasudil arm is administered twice a day, once in the morning and once in the evening, consistent with the product labeling in Japan.






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