Aerie Pharmaceuticals Initiates Phase 2b Clinical Trial of AR-15512 for the Treatment of Dry Eye Disease

Aerie Pharmaceuticals announced the commencement of COMET-1, a phase 2b clinical trial of AR-15512 (TRPM8 agonist) ophthalmic solution for the treatment of patients with dry eye disease.

The COMET-1 trial is a randomized, double-masked, vehicle-controlled trial evaluating the efficacy and safety of AR-15512 (TRPM8 agonist) in patients with dry eye disease. Approximately 360 patients in total are expected to be enrolled.

Patients will receive either AR-15512 0.0014%, AR-15512 0.003% or AR-15512 vehicle dosed as one drop twice daily in each eye over 3 months.The primary efficacy endpoints of the clinical trial are ocular discomfort (symptom) and tear production (sign).Patients will be evaluated on multiple efficacy assessments at days 14, 28 and 84; safety will be assessed at all visits. Topline results from COMET-1 are expected in the third quarter of 2021.

More information about the clinical trial is available at www.clinicaltrials.gov under the study designation NCT04498182.

“We are excited to initiate COMET-1, Aerie’s first dry eye clinical trial,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release. “With an estimated 30 million dry eye sufferers in the United States and less than 3 million treated, we believe there is a substantial unmet need in the treatment of dry eye disease. By activating the TRPM8 receptor, AR-15512 may stimulate tear production as well as reduce ocular discomfort through a mild cooling sensation. We anticipate topline results of COMET-1, which is powered as a Phase 3, in the third quarter of 2021.”

AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 in the acquisition of Avizorex Pharma, a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease.