Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency

Summary

STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.

Timeline

Start

2026-03-27

Primary completion

2027-03-31

Completion

2027-08-31

Publications

• Background Khalid M, Zahid E, Shaheer M. "Acoltremon: a novel advancement in dry eye disease management". Ann Med Surg (Lond). 2025 Oct 17;87(12):9121-9122. doi: 10.1097/MS9.0000000000004126. eCollection 2025 Dec. No abstract available.
• Background Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2026 May;133(5):563-574. doi: 10.1016/j.ophtha.2025.09.018. Epub 2025 Sep 30.
• Background Lee A. Acoltremon: First Approval. Drugs. 2025 Oct;85(10):1307-1310. doi: 10.1007/s40265-025-02218-5. Epub 2025 Jul 30.
• Background Zhou Y, Zhang W, Sun F. Acoltremon: The first TRPM8 agonist approved for the treatment of dry eye disease. Drug Discov Ther. 2025 Jul 4;19(3):210-211. doi: 10.5582/ddt.2025.01048. Epub 2025 Jun 27.
• Background Methods of Reducing Corneal Endothelial Cell Loss U.S. Patent Application, PCT/US2014/066551, filed November 20, 2014 Developed novel methodology to assess decreased nerve density in patients at risk for endothelial cell loss and preventing endothelial cell loss through neuropeptide based therapies.

Drugs

Indications