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

Aerie Pharmaceuticals 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%, administered once a day in the evening, to ripasudil hydrochloride hydrate ophthalmic solution 0.4%, marketed as Glanatec in Japan, administered twice a day, in the morning and evening.

The first patient to enter this randomized, single-masked, multicenter, 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.

“We are pleased that our clinical activities in Japan continue to advance with the completion of enrollment in this first phase 3 clinical trial. As we have stated previously, we expect to conduct a total of three phase 3 clinical trials for Rhopressa in Japan, two 4-week trials and one 12-month safety trial. We currently expect to complete the first phase 3 clinical trial by the end of 2021 and expect to report topline results from the trial shortly thereafter,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.

Aerie and Santen Pharmaceutical announced an exclusive collaboration and license agreement for Rhopressa and Rocklatan in Japan and several other Asian countries in October 2020. As part of this agreement, Santen is responsible for all development and commercialization costs and activities related to the products in the territories covered by the agreement; however, Aerie and Santen have collaborated for this first phase 3 study for Rhopressa in Japan, which they are co-funding.

The study was designed in accordance with the requirements of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to support a potential regulatory submission of netarsudil ophthalmic solution in Japan. The objective of the study, a superiority study, is to evaluate the ocular hypotensive efficacy and safety of netarsudil once daily compared to ripasudil twice daily, over a 4-week period in patients with primary open-angle glaucoma or ocular hypertension. More information about the study is available at www.clinicaltrials.gov under the study designation NCT04620135.

Netarsudil is marketed as Rhopressa in the United States where it is approved for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.