FDA

Tryptyr OK’d for dry eye disease

June 5, 2025

Brand name: Tryptyr

Generic name: acoltremon ophthalmic solution

Manufacturer: Alcon

Approval date: May 28, 2025

FDA approved Tryptyr (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of signs and symptoms of dry eye disease (DED).

According to a manufacturer press release, Tryptyr is a first-in-class transient receptor potential melastatin 8 (TRPM8) receptor agonist (neuromodulator) that stimulates corneal sensory nerves to rapidly increase natural tear production.

Efficacy

Approval was supported by two phase 3 clinical trials evaluating >930 patients (randomized 1:1 to Tryptyr or vehicle) with a history of DED. In COMET-2 (NCT05285644) and COMET-3 (NCT05360966), up to four times more Tryptyr patients experienced at least a 10 mm increase in natural tear production at day 14, compared with vehicle:

• 42.6% vs. 8.2% of patients in COMET-2
• 53.2% vs 14.4% in COMET-3, (both p<0.0001)

Consistent results were observed at all timepoints through day 90. Tryptyr led to statistically significant natural tear production as early as day one.

Safety

The most common adverse reaction was instillation site pain (50%).

Recommended dose

The recommended dosage of Tryptyr is one drop in each eye bid (approx. 12 hours apart).

Sources:

Tryptyr (acoltremon ophthalmic solution) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217370s000lbl.pdf Revised May 2025. Accessed June 4, 2025.

Alcon announces FDA approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease. [News release]. 2025. https://investor.alcon.com/news-and-events/press-releases/news-details/2025/Alcon-Announces-FDA-Approval-of-TRYPTYR-acoltremon-ophthalmic-solution-0-003-for-the-Treatment-of-the-Signs-and-Symptoms-of-Dry-Eye-Disease/default.aspx