Aerie Pharmaceuticals has initiated dosing in a phase 2 clinical trial of netarsudil ophthalmic solution in Japan, according to a press release.
In accordance with Japan’s Pharmaceuticals and Medical Devices Agency, the prospective, double-masked, multicenter, placebo-controlled, parallel group trial is being conducted as a precursor to phase 3 registration trials.
The IOP-reducing effect and safety of three concentrations of netarsudil (0.01%, 0.02% and 0.04%) will be evaluated over a 28-day period.
“Building upon the positive topline results of our pilot phase 2 study, we are very pleased to take this next step on the pathway toward a regulatory filing in Japan for netarsudil ophthalmic solution,” Vicente Anido Jr., PhD, chairman and CEO at Aerie, said in the release. “We anticipate completing enrollment in this study before the end of 2019 and then preparing for a netarsudil phase 3 program. We believe there continues to be substantial unmet need for novel glaucoma therapeutics in Japan, particularly medicines that are effective in patients with low baseline intraocular pressures.”