FDA advisory committee recommends Rhopressa (netarsudil ophthalmic solution) 0.02%, to treat glaucoma.-Aerie Pharmaceuticals.

Aerie Pharmaceuticals, Inc. announced that, in their review of Aerie product candidate Rhopressa (netarsudil ophthalmic solution) 0.02%, the members of Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA voted as follows on the two points for Advisory Committee consideration: 1. Do the clinical trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension? Results: (10-0) There were ten yes votes and zero no votes. 2. Does the efficacy of netarsudil ophthalmic solution, demonstrated in the clinical trials, outweigh the safety risks identified for the drug product? Results: (9-1) There were nine yes votes and one no vote.

In addition, there was general discussion on suggestions regarding the draft product labeling proposed by the FDA, which will ultimately be determined based on follow-on discussions between Aerie and the FDA. The goal date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is 28 February 2018. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines.