FDA accepts Aerie's resubmitted Rhopressa NDA

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) said FDA accepted for review its resubmitted NDA for Rhopressa netarsudil ophthalmic solution 0.02% (AR-13324) to treat intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. The PDUFA date is Feb. 28, 2018. Aerie said the agency plans to hold an advisory committee meeting to discuss the application.

The company withdrew the NDA in October 2016, saying a third-party manufacturer was not prepared for pre-approval inspection. Aerie had originally submitted the NDA in September 2016 (see BioCentury, Nov. 7, 2016)...