Treats dry eye disease. NDA 217370, held by Alcon Labs Inc. Acoltremon.
As of Nov 13, 2026, NDA 217370 (Tryptyr), held by Alcon Labs Inc, was first approved by FDA on May 28, 2025, with 0 approved supplements and 0 published complete response letters.
TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tryptyr0.003% · solution/drops;ophthalmic | Acoltremon | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
