Acoltremon
TRYPTYR
What it isTRPM8 cold-receptor agonist eye drop; dry eye disease.
Why this oneIt triggers the eye’s own basal tear reflex rather than lubricating or suppressing inflammation.
What limits itInstillation-site stinging. It relieves the deficiency, not the underlying inflammation.
FDA-approved for
- Dry eye disease (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Dry eye disease | Adults | Ophthalmic: 1 drop in each eye BID (~12 h apart) | 1 drop each eye BID | 1 drop each eye BID |
Renal Undefined
Hepatic Undefined
Instructions
- Wash hands before use; single-dose vial — use immediately after opening (one vial can dose both eyes), discard vial and remaining contents after use
- May be used with other topical ophthalmic drops; separate different ophthalmic drugs by >=5 min
- Remove contact lenses before instillation; may reinsert 15 min after
- If a dose is missed, continue with the next dose
Cautions
- Do not touch vial tip to the eye or other surfaces (eye injury/contamination risk)
- Do not administer while wearing contact lenses
Adverse reactions
- Instillation site pain (50%)
- Burning/stinging sensation (led to discontinuation in <1%)
Pregnancy No adequate human studies; systemic exposure from ocular use negligible; no embryofetal toxicity in rats/rabbits at 806- and 2151-fold the MRHOD.
Lactation No human milk data; systemic exposure after topical ocular use is low; weigh benefits of breastfeeding against clinical need.
NO BOXED WARNINGS
Principal riskInstillation-site stinging
Classes and tags
Clinical profile
Mechanism of action: Acoltremon ballicule
Open Acoltremon in the interactive console ↗
Memory aids: mascots and interaction avatars
