This article is more than 5 years old. Information may no longer be current.

Netarsudil ophthalmic solution trial begins in Japan

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Patient dosing has begun in a phase 2 clinical trial of Aerie Pharmaceuticals’ netarsudil ophthalmic solution for treatment of glaucoma, in accordance with Japan’s Pharmaceuticals and Medical Devices Agency regulations, according to a company press release.

Known as Rhopressa in the United States, netarsudil ophthalmic solution 0.02% has a PDUFA date of Feb. 28, 2018, with the FDA.

The study, which will be conducted in the United States, will include Japanese and Japanese-American subjects. Patients with open-angle glaucoma patients in the study will have baseline IOP of 15 mm Hg to less than 35 mm Hg, while patients with ocular hypertension will have IOP greater than 22 mm Hg to less than 35 mm Hg, the release said.

“Studies in Japan have shown that Japanese glaucoma patients experience IOPs that are generally lower than those experienced in the United States and Europe, hence the IOP ranges in this study start at 15 mm Hg. The Japanese glaucoma market is one of the largest in the world at approximately $1 billion annually, and we believe there continues to be substantial unmet need in this market,” Aerie chairman and CEO Vicente Anido Jr., PhD, said.