Posted by Michael Wonder on 15 May 2018
Aerie Pharmaceuticals submits new drug application to U.S. FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
15 May 2018 - Submitted as a 505(b)(2) with an expected ten month FDA review.
Aerie Pharmaceuticals today announced the submission of its new drug application to the U.S. FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%. Roclatan is a once-daily eye drop designed to reduce intra-ocular 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 (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, the results of which are included in the submission.
