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# Aerie Pharmaceuticals 505(b)(2) NDA for Roclatan Filed
- URL: https://www.fdaweb.com/aerie-pharmaceuticals-505-b-2-nda-for-roclatan-filed/
- Published: 2018-07-23T12:00:00.000Z
- Updated: 2026-09-15T00:21:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141938

FDA has accepted for review an Aerie Pharmaceuticals 505(b)(2) NDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, 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 (netarsudil ophthalmic solution) 0.02% and widely-prescribed 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 company says. The agency has set a user fee review action target date of 3/14/2019.