Tryptyr FDA Approval History
Last updated by Judith Stewart, BPharm on May 29, 2025.
FDA Approved: Yes (First approved May 28, 2025)
Brand name: Tryptyr
Generic name: acoltremon
Dosage form: Ophthalmic Solution
Company: Alcon Laboratories, Inc.
Treatment for: Dry Eye Disease
Tryptyr (acoltremon) is a first-in-class TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease.
- Dry Eye Disease (DED) is common disorder of the ocular surface that occurs when the eyes don't make enough tears to stay lubricated, or when the tears are of poor quality and therefore evaporate too quickly. Symptoms can include burning, itching, stinging, blurred vision, redness, and sensitivity to light.
- Tryptyr contains acoltremon, which is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. It is thought to work in the treatment of DED by activating trigeminal nerve signaling which leads to increased basal tear production.
- FDA approval of Tryptyr was supported by two Phase 3 clinical trials (COMET-2 and COMET-3) of more than 930 patients (randomized 1:1 to Tryptyr or vehicle) with a history of DED. In both trials, patients experienced at least a 10mm increase in natural tear production at Day 14, compared to vehicle (42.6% versus 8.2% of patients in COMET-2, and 53.2% versus 14.4% of patients in COMET-3 (both p<0.0001)). Patients using Tryptyr demonstrated statistically significant natural tear production as early as Day 1.
- Tryptyr is administered as one drop into each eye twice daily (approximately every 12 hours)
- Common adverse reactions include instillation site pain (50%).
Development timeline for Tryptyr
| Date | Article |
|---|---|
| May 28, 2025 | Approval FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease |
Further information
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