Aerie Pharmaceuticals announced the submission of its new drug application (NDA) to the FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) .02%/.005%. Roclatan is a once-daily eye drop designed to reduce 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 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 10 months instead of 12 months because Aerie’s submission is filed under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, because Roclatan is a fixed dose combination of two previously approved drugs in the United States.
“The Roclatan NDA filing represents another significant achievement for Aerie this year, on top of our recent commercial launch of Rhopressa in the United States. Since Roclatan is being filed through the 505(b)(2) regulatory pathway, in which both active ingredients, netarsudil and latanoprost, are already approved in the United States, we expect a 10-month FDA review. We believe, if approved, Roclatan has the potential to be the most efficacious therapy in the market for the reduction of IOP, which makes this submission all the more exciting for our valued employees, eye care professionals, and most importantly, patients who suffer from glaucoma or ocular hypertension,” Vicente Anido, Jr., PhD, Chief Executive Officer and Chairman at Aerie, said in a company news release.