Aerie completes enrollment in phase 2b trial for dry eye candidate
Aerie Pharmaceuticals has completed enrollment in a phase 2b clinical trial investigating AR-15512 ophthalmic solution for dry eye disease, according to a press release.
The randomized, double-masked, vehicle-controlled COMET-1 trial is evaluating the safety and efficacy of AR-15512 (TRPM8 agonist) in 369 patients who were randomly assigned to receive AR-15512 0.0014%, AR-15512 0.003% or AR-15512 vehicle.
“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,” Vicente Anido Jr., PhD, chairman and CEO at Aerie, said in the release.
Subjects received one drop twice daily in each eye over 3 months with evaluations occurring at 14, 28 and 84 days, the release said. Primary efficacy will be measured by ocular discomfort and tear production.
Aerie expects to report topline results in the third quarter.
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