FDA Approves Acoltremon Ophthalmic Solution (TRYPTYR) for Dry Eye Disease

The US Food and Drug Administration (FDA) has approved acoltremon ophthalmic solution .003% (TRYPTYR), formerly AR-15512, a first-in-class transient receptor potential melastatin 8 channel (TRPM8) receptor agonist that stimulates corneal sensory nerves, to treat signs and symptoms of dry eye disease (DED).1

DED is one of the most common ocular surface disorders in the world, affecting roughly 38 million adults in the US and 719 million more globally. Modern advancements in technology, resulting in prolonged screen exposure, have expanded DED from a disease traditionally affecting aging populations to one that impacts all ages and genders. Most existing prescription options for DED are considered by patients and clinicians as inadequate, citing low treatment efficacy and slow onset of action.2

“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 DED.”1

Announced by Alcon on May 28, 2025, the FDA’s decision comes on the heels of successful Phase 3 clinical trials – COMET-2 and COMET-3 – analyzing more than 930 patients. Both trials randomized participants 1:1 to acoltremon ophthalmic solution or vehicle control. The primary endpoint was the proportion of individuals with a ≥10 mm increase in unanesthetized Schirmer’s score across both trials. This endpoint reached statistical significance at Day 14, with 42.6% versus 8.2% of patients in COMET-2 and 53.2% versus 14.4% in COMET-3 (both P <.0001). These results were consistent through Day 90.1

Both trials’ secondary endpoints displayed rapid onset and sustained tear production associated with acoltremon ophthalmic solution compared to vehicle, manifesting at Day 1 and remaining until the end of the trial at Day 90. Additionally, acoltremon ophthalmic solution showed no serious ocular adverse events and was well-tolerated across both trials.2

Alcon acquired acoltremon ophthalmic solution through an acquisition of Aerie Pharmaceuticals, Inc. in November 2022, which came with the company’s existing pipeline of ophthalmic pharmaceutical product candidates. In addition to acoltremon ophthalmic solution, Alcon received ownership of netarsudil ophthalmic and latanoprost solution .02%/.005% (Rocklatan) and netarsudil ophthalmic solution) .02% (Rhopressa).3

Alcon has also announced its intention to launch acoltremon ophthalmic solution in the US during the third quarter of 2025 and anticipates bringing it to other markets in the future. Acoltremon ophthalmic solution will be available in single-dose vials, with one drop per eye twice daily.1

“Today marks a tremendous milestone for Alcon as TRYPTYR becomes our first prescription pharmaceutical treatment to be approved by the FDA since becoming an independent, publicly traded eye care company,” said David Endicott, chief executive officer of Alcon. “We look forward to making this new treatment available to millions of patients affected by DED. We believe TRYPTYR is an exciting new treatment option for a significant number of dry eye patients given its rapid efficacy.”

References

1. Alcon Announces FDA Approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the Treatment of the Signs and Symptoms of Dry Eye Disease. Alcon, Inc. May 28, 2025. Accessed May 29, 2025. https://www.alcon.com/media-release/alcon-announces-fda-approval-tryptyr-acoltremon-ophthalmic-solution-0003-treatment/

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

3. Alcon Completes Acquisition of Aerie Pharmaceuticals, Inc., Strengthening Company’s Ophthalmic Pharmaceutical Business. Alcon, Inc. November 22, 2022. Accessed May 29, 2025. https://www.alcon.com/media-release/alcon-completes-acquisition-aerie-pharmaceuticals-inc-strengthening-companys/