Aerie Pharma Offers Update on Safety Results for Rhospressa QD 0.02%

Aerie Pharmaceuticals, Inc.

, a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today reported an update including further details on the safety profile for RhopressaTM QD, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The Company previously reported interim topline 12-month safety and efficacy data on February 17, 2016, for Aerie's second Phase 3 registration trial for Rhopressa™ QD, indicating that RhopressaTM QD had a positive safety profile with sustained efficacy through the 12-month period. The Company expects to submit the NDA for RhopressaTM QD in the third quarter of 2016. Management will host a conference call and provide accompanying slides to discuss this update at 5:00 p.m. ET today. RhopressaTM QD Safety Update Highlights Detailed 90-day safety data from Rocket 1 and Rocket 2 for RhopressaTM QD were shared with the FDA during the Pre-NDA meeting that was held in October of 2015. Based on the RhopressaTM QD safety and efficacy data reviewed by the Company to date, and in consideration of the adverse event and efficacy profiles of other products currently in the market, the Company believes that product candidate RhopressaTM QD continues to have significant potential. Patients with contraindications to timolol, or beta blockers in general, or otherwise presenting with cardiopulmonary issues, were excluded from both Rocket 1 and Rocket 2. Based on Centers for Disease Control and Prevention data from 2011 and 2014, an estimated 47% of the U.S. population older than 65 years of age has heart disease and chronic obstructive pulmonary disease, all of which are contraindications to timolol.1,2 Since it is not systemically absorbed, RhopressaTM QD has not shown any drug-related systemic effects, nor has it generated any serious adverse events. Every other product in the adjunctive market for glaucoma and ocular hypertension has a history of drug-related systemic effects. RhopressaTM is being positioned to compete in the adjunctive market, which represents approximately half of the prescription volume for glaucoma products in the U.S. The most prevalent adverse event for RhopressaTM QD was conjunctival hyperemia, the large majority of which was considered mild. Fifty percent of Rhopressa™ QD patients experienced hyperemia at some point during the trial; however, only ten percent of the patients in the trial had hyperemia at each visit over the 12-month trial period. Other adverse events for RhopressaTM QD, including corneal deposits, conjunctival hemorrhages, blurry vision, and reduced visual acuity, all of which have been observed in safety data for other marketed products, were commonly sporadic or self-resolving for the 118 patients on RhopressaTM QD for the 12-month period in Rocket 2. Physicians' perspectives at the recent American Glaucoma Society Annual Meeting indicated a high level of interest in Rhopressa™ QD among glaucoma specialists due to its competitive efficacy, safety profile, once-daily dosing, adjunctive use with prostaglandins and novel mechanisms of action. The slides posted to the Aerie website include an in-depth analysis, including images where applicable, of the RhopressaTM QD adverse events noted in the safety data. "Consistent with what we previously reported, RhopressaTM QD continues to demonstrate a positive safety profile after our deeper dive into the safety data. We believe RhopressaTM , if approved, will be well-received by both ophthalmologists and the payer community. Our NDA filing remains on track for the third quarter of 2016," said Vicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman at Aerie. Dr. Anido continued, "When comparing the adverse event profile of RhopressaTM to the other market-leading products, along with the durable efficacy profile and mechanisms of action, we remain very excited about the prospects for RhopressaTM in the marketplace. The attributes of Rhopressa™ also confirm a very strong case for Roclatan™ which already showed a positive safety and efficacy profile in its Phase 2b trial." Richard A. Lewis, M.D., Aerie's Chief Medical Officer and a glaucoma specialist, stated, "Having attended the American Glaucoma Society meeting two weeks ago, it is clear to me that the ophthalmologists in the glaucoma community see RhopressaTM as an exciting new potential entrant in glaucoma therapy."