FDA approves acoltremon ophthalmic solution 0.003% for dry eye disease

The U.S. Food and Drug Administration has approved acoltremon ophthalmic solution 0.003% (TRYPTYR), formerly known as AR-15512, for the treatment of dry eye disease symptoms.

This first-in-class transient receptor potential melastatin 8 receptor agonist stimulates corneal sensory nerves to increase natural tear production rapidly following instillation.

The approval was based on results from 2 phase 3 clinical trials (COMET-2 and COMET-3) that evaluated 930 patients who were randomized 1:1 to acoltremon or vehicle. Acoltremon resulted in at least a 10-mm increase in natural tear production at day 14 in 42.6% of patients in COMET-2 and 53.2% of patients in COMET-3 versus just 8.2% and 14.4%, respectively, of patients treated with vehicle (P<0.0001). Acoltremon also demonstrated statistically significant natural tear production as early as day 1.

The recommended dose of acoltremon is 1 drop per eye, 2 times a day.

Source: Press Release

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