Aerie completes enrollment in phase 3 netarsudil trial in Japan
Aerie Pharmaceuticals has completed enrollment in a phase 3 trial in Japan investigating netarsudil in patients with primary open-angle glaucoma or ocular hypertension, according to a press release.
The randomized, single-masked, multicenter, parallel-group study includes 245 patients who were randomly assigned to receive once-daily netarsudil ophthalmic solution 0.02% or twice-daily ripasudil hydrochloride hydrate ophthalmic solution 0.4%. The superiority study is evaluating the ocular hypotensive efficacy and safety of netarsudil vs. ripasudil over a 4-week period.
“We are pleased that our clinical activities in Japan continue to advance with the completion of enrollment in this first phase 3 clinical trial,” Vicente Anido Jr., PhD, chairman and CEO at Aerie, said in the release. “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.”
In October 2020, Aerie and Santen announced a deal to develop and market Rhopressa (netarsudil ophthalmic solution 0.02%) and Rocklatan (netarsudil 0.02% and latanoprost 0.005% ophthalmic solution) in Japan and other Asian countries.