Aerie announces FDA advisory committee vote in favor of Rhopressa
Aerie Pharmaceuticals announced that, in their review of Aerie product candidate Rhopressa, the members of Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration voted as follows on the two points for Advisory Committee consideration: "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?" There were ten yes votes and zero no votes. "Does the efficacy of netarsudil ophthalmic solution, demonstrated in the clinical trials, outweigh the safety risks identified for the drug product?" There were nine yes votes and one no vote. The goal date for the FDA to take action under the Prescription Drug User Fee Act, or PDUFA, is February 28, 2018.