Last reviewed · How we verify
Tryptyr (ACOLTREMON)
Tryptyr works by modulating the function of the lacrimal gland to increase tear production.
At a glance
| Generic name | ACOLTREMON |
|---|---|
| Sponsor | Alcon Labs Inc |
| Drug class | TRPM8 Thermoreceptor Agonist [EPC] |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | FDA-approved |
| First approval | 2025 |
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.
Approved indications
- dry eye disease
- dry eye disease
Common side effects
- instillation site pain
- burning or stinging sensation in the eyes
Key clinical trials
- A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease (PHASE3)
- A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes (PHASE3)
- A Study Designed to Evaluate Tear Production (PHASE3)
- Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome (PHASE4)
- Investigator Initiated Trial Using Dry Eye Surveys to Evaluate and Better Understand FDA Approved Acoltremon Treatment for Dry Eye Disease in Real World Treatment Settings (DESERT) (PHASE4)
- Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon
- Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work (PHASE4)
- Switching From Xiidra to TRYPTYR (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tryptyr CI brief — competitive landscape report
- Tryptyr updates RSS · CI watch RSS
- Alcon Labs Inc portfolio CI