Aerie Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
Aerie Pharmaceuticals, Inc. (AERI)
Last aerie pharmaceuticals, inc. earnings: 2/20 04:01 pm
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Source: Business Wire
- Submitted as a 505(b)(2) with an Expected Ten-Month FDA Review - DURHAM, N.C.--(BUSINESS WIRE)-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), 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 and other diseases of the eye, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%. RoclatanTM 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®, which is currently available in the United States, and the widely-prescribed PGA (prostaglandin analog) latanoprost. RoclatanTM successfully achieved its primary efficacy endpoint in two Phase
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