Acoltremon

(Tryptyr®)

Tryptyr®

Drug updated on 6/11/2025

Dosage FormSolution (topical ophthalmic; 0.003% single-dose vial)
Drug ClassTRPM8 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
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  • 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 TitleYearSource
Tryptyr (acoltremon ophthalmic solution) Prescribing Information2025Alcon Laboratories, Inc., Fort Worth, TX

Randomized Controlled Trials