Aerie Pharmaceuticals, Inc., an ophthalmic pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retina diseases and other diseases of the eye, today reported that it has received the “Day 74” notification from the FDA earlier than scheduled, the FDA has completed its initial 60-day review of the NDA (new drug application) for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02 percent/0.005 percent and the FDA has determined that the application is sufficiently complete to permit a substantive review.
The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Roclatan NDA is set for March 14, 2019. This date reflects a standard 10-month review period and is consistent with management’s expectations for the 505(b)(2) filing. The “Day 74” notification indicated that the FDA has not identified any potential review issues, and did not mention the need for an advisory committee.
“We are delighted with this positive news on our Roclatan NDA, and, if approved, we expect to be fully prepared to launch Roclatan using our existing sales force, which is already making excellent progress in the early months of our Rhopressa launch,” said Vicente Anido, Jr., Ph.D., chairman and CEO at Aerie.
Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02 percent/0.005 percent, is a once-daily eye drop designed to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. It is a fixed dose combination of Aerie’s Rhopressa (netarsudil ophthalmic solution) 0.02 percent, which is currently available in the United States, and widely-prescribed PGA (prostaglandin analog) latanoprost. Roclatan successfully achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1.
Aerie submitted the Roclatan New Drug Application (NDA) with the FDA in May 2018 and, in July 2018, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Roclatan NDA for March 14, 2019. A third Phase 3 trial for Roclatan, named Mercury 3, is currently underway in Europe but is not required for approval in the United States.
(Source: Aerie Pharmaceuticals, Inc.)
Filed Under: Drug Discovery