AERI

AR-15512 (TRPM8 agonist eye drop)

Dry Eye Disease (DED)

Stage (next event)

Expected Date

Phase 2b (COMET-1) readout

Q3 2021

Catalyst Info & Data Links

TITLE: AR-15512 for Dry Eye Disease - Phase 2b

  • A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

WHAT IS THE NEXT CATALYST EVENT?

  • Phase 2b data readout

WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • TBD (initiated Q4 2020)

AR-15512, formerly AVX-012, was acquired by Aerie in November 2019 in the acquisition of Avizorex Pharma, S.L., a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease. The active ingredient in AR-15512 is a potent and selective agonist of the TRPM8 cold thermoreceptor ion channel that regulates tear production and blink rate. By stimulating these processes, TRPM8 agonists have the potential to restore tear film volume and reduce ocular discomfort in patients with dry eye. Avizorex completed a Phase 2a study in dry eye subjects in 2019 where positive results support the therapeutic potential to treat signs and symptoms of dry eye.


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 three 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,” said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “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, S.L., a Spanish ophthalmic pharmaceutical company developing therapeutics for the treatment of dry eye disease.

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