Acoltremon

Treats dry eye disease. Sold as Tryptyr. Every FDA application for this active ingredient.

As of Nov 14, 2026, FDA lists 1 application for Acoltremon (sold as Tryptyr), first approved May 28, 2025, with 0 new uses approved and 0 published complete response letters.

First approved: May 28, 2025
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $7.4M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Tryptyr	Part D	$7.4M	New	4,120

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

TRYPTYR 0.003% EYE DROP: $14.07 per unitBrand · new this year

Who Was in the Trials

931 participants in the largest population FDA reports for the May 28, 2025 approval, from FDA's Drug Trials Snapshot; see every snapshot

Women: 75%
65 and older: 45%
White: 76%
Black: 14%
Asian: 8%
Hispanic or Latino: 12%

Clinical Trials

14 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effectiveness Study of TRYPTYR in Dry Eye DiseaseDry Eye Disease · Scott & Christie and Associates, PC	—	Recruiting	Nov 9, 2026
Evaporative Dry EyeDry Eye, Evaporative Dry Eye · Southern College of Optometry	Phase 4	Not yet recruiting	Oct 28, 2026
Cooling Eyedrops for Dry EyeDry Eye · University of California, Berkeley	Phase 4	Not yet recruiting	Oct 22, 2026
Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal PainOcular Pain, Dry Eye · University of South Florida	Phase 4	Not yet recruiting	Sep 30, 2026
Contact Lens-Wearing Dry Eye Subjects Who Are Treated With Acoltremon 0.003%Dry Eye, Contact Lens Discomfort · Eye Research Associates, LLC	Phase 4	Not yet recruiting	Sep 30, 2026
TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)Dry Eye Disease (DED) · NYU Langone Health	Phase 4	Recruiting	Jul 28, 2026
Long-term Effects of Acoltremon vs. Control in Dry Eye DiseaseDry Eye · The Eye Care Institute	—	Recruiting	Jun 22, 2026
Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear DeficiencyOcular Surface Disease, Neurotrophic Keratopathy Stage 1 · University of South Florida	Phase 4	Recruiting	Mar 31, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
May 28, 2025	TryptyrNDA 217370 · New molecular entity	Alcon Labs Inc	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA