Tryptyr (acoltremon) is filed as TRPM8 Thermoreceptor Agonist [EPC]. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
12.1 Mechanism of Action Studies in animals suggest that acoltremon, the active substance in TRYPTYR, is an agonist of transient receptor potential melastatin 8 (TRPM8) thermoreceptors. TRPM8 thermoreceptor stimulation has been shown to activate trigeminal nerve signaling leading to increased basal tear production. The exact mechanism of action for TRYPTYR in dry eye disease is unknown.
5 WARNINGS AND PRECAUTIONS To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. ( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. 5.2 Use with Contact Lenses TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR.
4 CONTRAINDICATIONS None. None. ( 4 )
Instillation site pain (50%)
6 ADVERSE REACTIONS The most common adverse reaction was instillation site pain (50%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9780, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States. The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%). Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.
2 DOSAGE AND ADMINISTRATION Instill one drop in each eye twice daily (approximately 12 hours apart). ( 2 ) 2.1 Recommended Dosage Instill one drop in each eye twice daily (approximately 12 hours apart). 2.2 Administration Instructions Wash hands before use. The single-dose vials are to be used immediately after opening and can be used to dose both eyes. Discard the single-dose vial, including any remaining contents, immediately after use. TRYPTYR can be used concomitantly with other topical ophthalmic eye drops. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart . Contact lenses should be removed prior to the administration of TRYPTYR and may be reinserted 15 minutes following administration. If one dose is missed, treatment should continue with the next dose.
According to its FDA label, Tryptyr (acoltremon) is approved for: 1 INDICATIONS AND USAGE TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 ) For medical advice, please talk to your prescriber or pharmacist.
Tryptyr (acoltremon) belongs to the TRPM8 Thermoreceptor Agonist [EPC] class of medications.
The FDA label lists Tryptyr (acoltremon) as: 3 DOSAGE FORMS AND STRENGTHS TRYPTYR is a clear to slightly opalescent, colorless ophthalmic solution containing 0.003% acoltremon in a single-dose vial. Ophthalmic solution: 0.003% acoltremon in a single-dose vial. ( 3 ); ophthalmic route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Tryptyr. Availability changes as patents expire.
Our ingest of the FDA label for Tryptyr (acoltremon) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Tryptyr (acoltremon) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Tryptyr (acoltremon) as 2025-05-28.
The FDA label lists Alcon Laboratories, Inc. as a labeler/manufacturer of Tryptyr (acoltremon). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage Store refrigerated at 2°C to 8°C (36°F to 46°F). After opening the carton, TRYPTYR may be stored refrigerated or at room temperature at 2°C to 25°C (36°F to 77°F). If stored at room temperature, TRYPTYR should be…" Follow the packaging insert for the authoritative guidance.
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