Phase 2b trial for Aerie dry eye drop begins
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A phase 2b clinical trial of AR-15512 ophthalmic solution for the treatment of dry eye disease has been initiated, according to a press release from Aerie Pharmaceuticals.
COMET-1 is a randomized, double-masked, vehicle-controlled trial investigating the safety and efficacy of AR-15512, a TRPM8 agonist. The trial aims to enroll about 360 patients who will receive AR-15512 0.0014%, AR-15512 0.003% or AR-15512 vehicle, one drop twice daily in each eye for 3 months. Primary endpoints include ocular discomfort and tear production, and patients will be evaluated at days 14, 28 and 84, the release said.
“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,” Vicente Anido Jr., PhD, Aerie chairman and CEO, said in the release.
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