FDA approves new first-in-class treatment for symptoms of dry eye disease

The U.S. Food and Drug Administration approved acoltremon ophthalmic solution 0.003% (TRYPTYR) to treat the signs and symptoms of dry eye disease.

The decision was based on results from 2 phase 3 clinical trials that included 930 patients who were randomized 1:1 to acoltremon or vehicle. Four times as many patients treated with acoltremon experienced a 10-mm increase in natural tear production at day 14 compared with vehicle (P<0.0001):

• COMET-2: 42.6% vs 8.2%
• COMET-3: 53.2% vs 14.4%

Acoltremon also demonstrated statistically significant natural tear production at as early as day 1.

This first-in-class transient receptor potential melastatin 8 receptor agonist, formerly known as AR-15512, stimulates corneal sensory nerves to increase natural tear production rapidly following instillation.

Acoltremon is administered as 1 drop per eye, 2 times a day.

Source: Press Release