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Alcon Announces FDA Approval of TRYPTYR (Acoltremon Ophthalmic Solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease

  • On May 31, 2025, Alcon announced that the U.S. FDA granted approval for TRYPTYR 0.003% to treat the signs and symptoms associated with dry eye disease.
  • The approval followed two phase 3 trials, COMET-2 and COMET-3, involving over 930 patients with dry eye disease who were randomized 1:1 to TRYPTYR or vehicle.
  • TRYPTYR acts as a TRPM8 receptor agonist by activating corneal sensory nerves, which quickly enhances the eye’s natural tear flow and targets the inadequate tear levels that contribute to dry eye disease.
  • In the COMET-2 study, 42.6% of patients treated with TRYPTYR showed an improvement of 10 mm or more in tear secretion by the two-week mark, compared to 8.2% of those receiving the vehicle, with statistically significant differences observed as early as Day 1.
  • The approval suggests a new rapid-acting treatment option addressing limitations of prior therapies, potentially improving patient outcomes for the many who report unsatisfactory management of dry eye disease.
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The Huntsville Item broke the news in on Wednesday, May 28, 2025.
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