FDA reviewing Aerie's resubmitted NDA

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

Aerie withdrew the NDA in October 2016, saying a third-party manufacturer was not prepared for pre-approval inspection. The candidate, a dual inhibitor of Rho kinase and the norepinephrine transporter, met the primary endpoint of the Phase III Rocket 2 study, improving intraocular pressure (IOP) compared to timolol (see BioCentury Extra, Feb. 18, 2016)...