What Was Approved?
On May 28, 2025, the U.S. Food and Drug Administration approved Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease in adults.
How Does Tryptyr Work?
Tryptyr is a TRPM8 thermoreceptor agonist.
It stimulates sensory pathways involved in tear production and is intended to help improve symptoms and signs associated with dry eye disease.
How Is Tryptyr Used?
The recommended dosage is:
One drop in each eye twice daily, approximately 12 hours apart.
Tryptyr is for ophthalmic use only.
What Did the Clinical Trials Show?
FDA approval was supported by the COMET-2 and COMET-3 trials involving 931 adults with dry eye disease.
The studies evaluated both signs and symptoms of dry eye disease compared with vehicle treatment.
These results do not guarantee the same degree of improvement for every patient.
What About Contact Lenses?
The FDA review specifically added precautions related to contact lens use.
Patients who wear contact lenses should follow the product-specific instructions and discuss proper timing with their eye-care professional.
Bottom Line
Tryptyr (acoltremon ophthalmic solution) is an FDA-approved twice-daily eye drop for adults with dry eye disease.
It treats both signs and symptoms of dry eye disease and should be used according to the ophthalmic dosing instructions provided with the product.
Sources
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Tryptyr.
- U.S. Food and Drug Administration (FDA) — Tryptyr Prescribing Information and Instructions for Use, 2025.
- U.S. Food and Drug Administration (FDA) — Tryptyr Integrated Review.