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Aerie Pharmaceuticals Completes Enrollment of Mercury 1 Phase 3 Registration Trial of RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

IRVINE, Calif., May 05, 2016 (BUSINESS WIRE) -- Aerie Pharmaceuticals, Inc. AERI, -0.19% a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced the completion of patient enrollment in the Company’s initial Phase 3 registration trial (“Mercury 1”) of Roclatan [TM] (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Roclatan [TM] is a fixed dose combination of Aerie drug Rhopressa [TM] (netarsudil ophthalmic solution) 0.02% and latanoprost, the most widely prescribed PGA (prostaglandin analogue). Mercury 1 has total enrollment of approximately 690 patients in this three-arm study, designed to demonstrate superiority of Roclatan [TM] to each of its two components, all dosed once daily in the evening. The range for the primary endpoint evaluates patients with maximum baseline IOPs ranging from above 20 to below 36 mmHg (millimeters of mercury). Mercury 1, which commenced in September 2015 is a twelve-month safety trial with a 90-day interim efficacy readout that is expected in the third quarter of 2016. In March 2016, the Company commenced a second Phase 3 registration trial for Roclatan [TM] , Mercury 2, which is a 90-day efficacy trial, and also plans to commence in the first half of 2017 a third Phase 3 clinical trial for Roclatan [TM] , named Mercury 3, which will be designed to facilitate regulatory approval and commercialization in Europe.

“With the completion of Mercury 1 enrollment, we remain well-positioned for the topline 90-day interim efficacy readout from this trial by the end of the third quarter of 2016. Mercury 2 is also well underway from an enrollment perspective. Should both Mercury 1 and Mercury 2 be successful, we continue to expect to file an NDA for Roclatan [TM] in the second half of 2017, just a year behind the expected Rhopressa [TM] NDA filing,” said Vicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman at Aerie. “We have observed very high levels of interest in Roclatan [TM] from the ophthalmology community, and we look forward to the continued successful progress of our registration program.”

About Roclatan™

Roclatan™ is a once-daily eye drop that combines our triple-action Rhopressa™ with latanoprost, a PGA that is the most widely prescribed glaucoma drug. We believe that Roclatan™, if approved, would be the first glaucoma product to lower IOP through all known mechanisms: (i) increasing fluid outflow through the...