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Review
. 2025 Oct;85(10):1307-1310.
doi: 10.1007/s40265-025-02218-5. Epub 2025 Jul 30.

Acoltremon: First Approval

Arnold Lee  1
Affiliations
Review

Acoltremon: First Approval

Arnold Lee. Drugs. 2025 Oct.

Abstract

Acoltremon (TRYPTYR®) is a TRPM8 thermoreceptor agonist formulated as eye drops, which has been developed by Alcon for the treatment of dry eye disease. As an insufficient aqueous layer is linked to dry eye disease, the stimulation of tear production by acoltremon can relieve symptoms associated with dry eye disease. During phase III trials in patients with dry eye disease, acoltremon demonstrated increased tear production with a low treatment discontinuation rate. This article summarizes the milestones in the development of acoltremon leading to this first approval for the treatment of the signs and symptoms of dry eye disease.

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Conflict of interest statement

Declarations. Funding: The preparation of this review was not supported by any external funding. Authorship and Conflict of Interest: During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Arnold Lee is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content. Ethics Approval, Consent to Participate, Consent to Publish, Availability of Data and Material, Code Availability: Not applicable.

References

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    1. Alcon Laboratories. Alcon announces FDA approval of TRYPTYR (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease [media release]. 28 May 2025. https://www.alcon.com .
    1. Alcon Laboratories. TRYPTYR (acoltremon ophthalmic solution) 0.003% for topical ophthalmic use: US prescribing information. 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217370s000lbl.pdf . Accessed 22 Jul 2025.
    1. Avizorex Pharma. AVIZOREX PHARMA, SL receives Notice of Allowance for U.S. Patent on AVX-012 compositions and methods of treatment for dry eye syndrome [media release]. 3 Mar 2015
    1. Alcon Laboratories. Alcon completes acquisition of Aerie Pharmaceuticals, Inc., strengthening companys ophthalmic pharmaceutical business [media release]. 22 Nov 2022. https://www.alcon.com .

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