Aerie Pharmaceuticals announced that a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA has been scheduled for October 13, 2017 to review the company’s new drug application (NDA) for Rhopressa (netarsudil ophthalmic solution) 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. Aerie submitted the NDA for Rhopressa to the FDA in February 2017, following which the FDA set a PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018 for the completion of its review of the Rhopressa NDA.
“This is another key step as we progress toward our Rhopressa PDUFA date in February. We have been actively preparing for this meeting since May 2017, and have conducted several practice panel sessions, including with experts in the fields of ophthalmology and glaucoma, dermatology and statistics. We are highly prepared for this meeting and very much look forward to sharing our Rhopressa data with the Advisory Committee,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.