Aerie Pharmaceuticals announced that the FDA has reviewed the investigational new drug application (IND) for AR-15512 (TRPM8 agonist) eye drop for dry eye and it is now in effect, allowing Aerie to initiate clinical studies in the treatment of dry eye. Aerie expects to initiate a phase 2b clinical study in the fourth quarter of 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 acceptance of the IND for AR-15512 marks the first clinical-stage dry eye product candidate for Aerie, another important milestone for the company. We expect to commence a phase 2b clinical study, which will be powered as a phase 3 later this year, with a topline readout expected in the third quarter of 2021,” Vicente Anido, Jr., PhD, Chairman and Chief Executive Officer at Aerie, said in a company news release.