CHICAGO—Aerie’s CEO and chairman, Vincent Anido, Jr., PhD, has said the company’s goal is to become a major ophthalmic pharmaceutical firm by using Rho-kinase inhibitors to treat ocular disease. Its first two products, Rhopressa (netarsudil ophthalmic solution 0.02%) and Roclatan (Rhopressa and latanoprost 0.005%) have shown good response in clinical trials. Rhopressa is awaiting US regulatory approval and Roclatan is undergoing two Phase III studies, with the first finding the compound achieved its primary efficacy endpoint.
Preclinical research includes programs for Rhopressa as a disease-modifying or neuroprotective agent, AR-13154 for the treatment of wet age-related macular degeneration, and drug delivery products to deliver therapeutics to the anterior and posterior segments, Dr. Anido said here during the Ophthalmic Innovation Summit.
Rhopressa underwent one of the largest clinical studies to date for the treatment of glaucoma – a total of 1,165 patients were enrolled in the various arms, and the positive outcomes showed not only statistical superiority to timolol, with no serious safety issues.
Roclatan has enrolled about 690 patients in a three-month interim efficacy study and one-year safety study; a second 690-patient registration trial study in the US and Canada evaluated the efficacy of the drug over 90 days, and a third 460-patient registration trial in Europe is evaluating the six-month efficacy and safety of the drug. In the first of these studies, Roclatan achieved statistical superiority over the individual components at all time points and at pressures of 16 mm Hg or less, 15 mm Hg or less, and 14 mm Hg or less. At Day 90, 61% of patients in the Roclatan arm had pressures under 16 mm Hg (compared with 39% in the latanoprost arm and 32% in the Rhopressa arm).
“The main adverse event was conjunctival hyperemia, which occurred in about 50% of patients and was scored as mild in about 80%,” Anido said. Top-line results from the second study are expected in the first half of 2017, and an efficacy study enrolling patients in Europe is expected to being[begin?] in that same time frame.
Anido expects Aerie will submit Roclatan for US approval near year-end 2017.
Vicente Anido Jr., PhD
Vicente Anido, Jr., PhD currently serves as CEO and Chairman of the Board of Aerie Pharmaceuticals, Inc., a publicly traded, 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.