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

Aerie submits NDA for Roclatan

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

Aerie Pharmaceuticals has submitted a new drug application to the FDA for Roclatan, its once-daily IOP-lowering eye drop, the company announced in a press release.

As a fixed-dose combination of two previously approved drugs, the expected FDA review period for Roclatan (netarsudil 0.02%/latanoprost 0.005% ophthalmic solution) is 10 months rather than 12 months under section 505(b)(2) of the Food, Drug and Cosmetic Act, the release said.

“We believe, if approved, Roclatan has the potential to be the most efficacious therapy in the market for the reduction of IOP, which makes this submission all the more exciting for our valued employees, eye care professionals, and most importantly, patients who suffer from glaucoma or ocular hypertension,” Vicente Anido Jr., PhD, Aerie CEO and chairman, said in the release.