Acoltremon significantly improved tear production and dry eye symptoms compared with vehicle in two Phase 3 trials, showing rapid onset, sustained benefit, and good tolerability, according to a study.
In the trials, nearly 1,000 adults with moderate dry eye disease (DED) were randomized to receive either acoltremon 0.003% or vehicle drops twice daily for 90 days. By day 14, a markedly higher proportion of patients treated with acoltremon achieved at least a 10-mm increase in tear production compared with vehicle (42.6% vs 8.2% in COMET-2; 53.2% vs 14.4% in COMET-3; P < 0.0001).
Acoltremon also produced early and sustained increases in tear production from day 1 through day 90, along with improvements in ocular discomfort scores and corneal and conjunctival staining. Mild burning or stinging at the time of instillation was the only notable adverse effect.
Overall, results from both studies indicate that acoltremon provides rapid, meaningful relief of DED signs and symptoms with a favorable safety profile.
Reference
Pattar GR, Wirta D, Jerkins G, et al; 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 Studies COMET-2 and COMET-3. Ophthalmology. 2025;S0161-6420(25)00605-0. doi: 10.1016/j.ophtha.2025.09.018. Epub ahead of print. PMID: 41038456.
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