Study Evaluating the Safety and Efficacy of AR-15512

Summary

This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.

Timeline

Start

2022-05-09

Primary completion

2023-07-24

Completion

2023-07-24

Outcome

Met primary endpoint

paper The primary end point was met in both studies, with more patients receiving ACO achieving a 10-mm or greater increase in UST on day 14 PMID 41038456 ↗

paper ACO vs. vehicle: COMET-2, 42.6% vs. 8.2%; COMET-3, 53.2% vs. 14.4%; P < 0.0001 for both PMID 41038456 ↗

Publications

• Periman LM, Lappin CJ, McDonald MB, Coats J, Pattar GR, Okoro T, Lighthizer N, Senchyna M, Nijm LM. Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. Ophthalmol Ther. 2026 Jul 18. doi: 10.1007/s40123-026-01421-1. Online ahead of print.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acoltremon	Small molecule	0.003 %	Topical

Indications