Drug updated on 6/11/2025
Dosage Form | Solution (topical ophthalmic; 0.003% single-dose vial) |
Drug Class | TRPM8 thermoreceptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of the signs and symptoms of dry eye disease
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Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Tryptyr (acoltremon) is indicated for the treatment of the signs and symptoms of Dry Eye Disease (DED).
- In patients with DED, the 0.003% concentration of AR-15512 resulted in statistically significant improvements in ocular surface staining at Days 14 and 84 (p ≤ 0.0365), hyperemia at Day 84 (p < 0.0215), and unanesthetized Schirmer score at Days 1 and 14 (p < 0.0001).
- Statistically significant symptom relief was observed with 0.003% AR-15512 in Symptom Assessment in Dry Eye (SANDE) scores at Days 14, 28, and 84 (p ≤ 0.0254), Ocular Discomfort and Severity–Visual Analog Scale (ODS-VAS) at Day 84 (p = 0.0281), and Eye Dryness–Visual Analog Scale (Eye Dryness-VAS) at Day 84 (p = 0.0302). Quality of life measures showed statistically significant improvement at Days 14, 28, and 84 with the 0.003% concentration of AR-15512 (p < 0.05).
- In patients with DED, the most common adverse events reported with AR-15512 0.003% were burning and stinging upon instillation.
- No significant safety concerns or adverse effects beyond burning and stinging were noted.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tryptyr (acoltremon ophthalmic solution) Prescribing Information | 2025 | Alcon Laboratories, Inc., Fort Worth, TX |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
A randomized, vehicle-controlled, Phase 2b study of two concentrations of the TRPM8 receptor agonist AR-15512 in the treatment of dry eye disease (COMET-1) | 369Subjects F: 72% M: 28% | 2022 | The Ocular Surface |
Sex Distribution:
F:72%
M:28%
369Subjects
Year:
2022
Source:The Ocular Surface