DURHAM, N.C.– Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, ocular surface diseases and retinal diseases, today announced the completion of patient enrollment for COMET-1, a Phase 2b clinical trial of AR-15512 (TRPM8 Agonist) (“AR-15512”) ophthalmic solution for the treatment of patients with dry eye disease.
The first patient to enter this randomized, double-masked, vehicle-controlled Phase 2b clinical trial evaluating the efficacy and safety of AR-15512 in patients with dry eye disease was dosed in October 2020. A total of 369 patients were randomized across three arms, AR-15512 (0.0014%), AR-15512 (0.003%) or AR-15512 vehicle. Patients were given one drop twice daily in each eye over three months. Patients are evaluated at days 14, 28 and 84, with the primary efficacy measures of ocular discomfort (a symptom) and tear production (a sign). The regulatory pathway for dry eye product approval requires that both safety and efficacy need to be demonstrated in at least 2 well-controlled clinical trials. Efficacy for sign and symptom do not need to be shown in the same trial but both have to be shown in multiple trials. More information about the clinical trial is available at www.clinicaltrials.gov under the study designation NCT04498182.
“With an estimated 30 million dry eye sufferers in the United States and less than 3 million treated, there remains a significant unmet need in the treatment of dry eye disease. When activated, the TRPM8 receptor may increase tear production, a sign for dry eye disease, and its cooling sensation may lead to reduction in discomfort and ocular pain, a symptom of dry eye disease. This unique mechanism of action targeting both the signs and symptoms of dry eye disease is different from currently marketed eye products and we believe has the potential for use as a monotherapy and in conjunction with other approved products,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “We are pleased that our dry eye clinical activities continue to advance with the completion of enrollment in this Phase 2b clinical trial, COMET-1. We currently expect to report topline results for this trial in the third quarter of this year.”
AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 in connection with the acquisition of Avizorex Pharma, S.L., a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease. AR-15512 has intellectual property protection for pharmaceutical composition and method of use through 2031.
