17 May 2018 - - Irvine, California-based ophthalmic pharmaceutical company Aerie Pharmaceuticals, Inc. (NASDAQ: AERI) has submitted its new drug application (NDA) to the US Food and Drug Administration for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, the company said.
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 US, 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 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 US.
Aerie is focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma or ocular hypertension and other diseases of the eye.