Aerie Pharmaceuticals Announces FDA Advisory Committee Vote in Favor of Rhopressa 0.02%

From Drugs.com - October 13, 2017

Rhopressa

Treatment for Glaucoma

Aerie Pharmaceuticals Announces FDA Advisory Committee Vote in Favor of Rhopressa (netarsudil ophthalmic solution) 0.02%

IRVINE, Calif.--(BUSINESS WIRE)--Oct. 13, 2017-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today announced that, in their review of Aerie product candidate Rhopressa (netarsudil ophthalmic solution) 0.02%, the members of Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted as follows on the two points for Advisory Committee consideration:

1. Do the clinical trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension?

Results: (10-0) There were ten yes votes and zero no votes.

2. Does the efficacy of netarsudil ophthalmic solution, demonstrated in the clinical trials, outweigh the safety risks identified for the drug product?

Results: (9-1) There were nine yes votes and one no vote.

In addition, there was general discussion on suggestions regarding the draft product labeling proposed by the FDA, which will ultimately be determined based on follow-on discussions between Aerie and the FDA.

The goal date for the FDA to take action under the Prescription Drug User Fee Act (PDUFA) is February 28, 2018. The FDA is not bound by the Advisory Committee's guidance, but takes its advice into consideration when reviewing investigational medicines.

We are delighted with the outcome of the FDAs Advisory Committee, and we now have our sights set on the February 28th PDUFA date. We believe there are significant unmet needs in the treatment of patients with open-angle glaucoma or ocular hypertension, and we are very excited about the prospects for RhopressaTM, said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.

About Rhopressa

Rhopressa (netarsudil ophthalmic solution) 0.02%, is a novel eye drop that the Company believes, if approved, would become the only once-daily product available that, based on Aeries preclinical and clinical studies to date, specifically targets the trabecular meshwork, the eyes primary fluid drain and the diseased tissue responsible for elevated intraocular pressure (IOP) in glaucoma. Preclinical and clinical studies have also demonstrated that Rhopressa lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, based on Aeries preclinical studies, Rhopressa may provide an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, the active ingredient in Rhopressa, netarsudil, has been shown in Aerie studies to inhibit both Rho kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have also shown that Rhopressa may have disease-modifying properties, including an anti-fibrotic effect of netarsudil on trabecular meshwork cells and the potential to increase perfusion of the trabecular meshwork.

About Aerie Pharmaceuticals, Inc.

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