Aerie Pharmaceuticals submits NDA to FDA for Roclatan
Aerie Pharmaceuticals announced the submission of its New Drug Application to the U.S. FDA for Roclatan 0.02%/0.005%. Roclatan is a once-daily eye drop designed to reduce intraocular pressure 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 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, the results of which are included in the NDA submission. The expected FDA review period for Roclatan NDA is only ten months instead of twelve months because Aerie's submission is filed under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, since Roclatan is a fixed dose combination of two previously approved drugs in the United States.