FDA approves Aerie's Rhopressa

FDA approved Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company plans to launch the drug in 2Q18.

The approval comes more than two months ahead of Rhopressa’s Feb. 28 PDUFA date. In October, FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted 9-1 that Rhopressa's efficacy shown in clinical trials outweighs the drug's safety risks (see BioCentury Extra, Oct. 13)...