Alcon Secures FDA Approval for TRYPTYR (Acoltremon Ophthalmic Solution) 0.003% for Dry Eye Disease

TRYPTYR, the first TRPM8-targeting eye drop, improves tear production from Day 1 in dry eye patients.

Alcon (Geneva, Switzerland) has announced that the U.S. Food and Drug Administration (FDA) has approved TRYPTYR (acoltremon ophthalmic solution) 0.003%, formerly known as AR-15512, for the treatment of the signs and symptoms of dry eye disease (DED).

TRYPTYR is a first-in-class TRPM8 receptor agonist (neuromodulator) that stimulates trigeminal nerve signaling to rapidly increase basal tear production when activated. The drug will be available in easy-to-use, single-dose vials, with one drop per eye, twice daily.

This marks the first prescription pharmaceutical treatment Alcon has received FDA approval for since becoming an independent, publicly traded company, according to Alcon CEO David Endicott. ” We believe TRYPTYR is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy.”

What did the clinical trials show?

FDA approval for TRYPTYR was based on two pivotal Phase III trials—COMET-2 and COMET-3—evaluating over 930 patients with a history of DED.¹

Key findings include:

In COMET-2, 42.6% of TRYPTYR patients experienced at least a 10 mm increase in natural tear production at Day 14, compared to 8.2% in the vehicle group (p<0.0001).¹
In COMET-3, 53.2% of TRYPTYR patients achieved the same result, compared to 14.4% in the vehicle group (p<0.0001).
Results were consistent across all timepoints through Day 90.
TRYPTYR showed statistically significant tear production as early as Day 1.

“Many of my patients continue to face frustrating challenges with dry eye management, and there is a clear need for additional treatment options,” said Marjan Farid, MD, professor of ophthalmology at the University of California, Irvine. “TRYPTYR is the first eye drop that stimulates corneal nerves to directly address tear deficiency, a known cause of dry eye disease.”

Alcon expects to launch TRYPTYR in the U.S. market in the third quarter of 2025. The company also anticipates expanding availability to other markets in the future.

Editor’s note: For further information, see Alcon press release and click here for the TRYPTYR full prescribing information. This information is intended for eye care professionals only. The product(s) mentioned may not be approved for use in all territories.

Reference

Alcon. Press release. Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye. Published on January 9, 2024. Available at: https://www.alcon.com/media-release/alcon-announces-positive-topline-results-phase-3-comet-trials-ar-15512-novel-topical/. Accessed on May 29, 2025.