Phase 3 COMET trials of dry eye candidate meet primary endpoint
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Key takeaways:
- AR-15512 demonstrated positive efficacy and safety results for the treatment of dry eye disease.
- COMET-2 and COMET-3 achieved the primary endpoint.
Two pivotal phase 3 clinical trials evaluating the efficacy and safety of AR-15512 for treating the signs and symptoms of dry eye disease achieved the primary endpoint, according to a press release from Alcon.
The COMET-2 and COMET-3 trials enrolled and randomly assigned more than 930 participants with dry eye disease to treatment with either AR-15512, a topical transient receptor potential melastatin 8 agonist, or vehicle control.
The primary endpoint of both trials was the proportion of subjects with at least a 10 mm increase in unanesthetized Schirmer’s score, and this was achieved with statistical significance at day 14 (P < .0001).
In addition, AR-15512 demonstrated rapid onset and sustained tear production compared with vehicle “as early as day 1 and persistent to day 90,” the release said.
The candidate was well tolerated, with no reports of serious ocular adverse events.
“A key gap in dry eye medications is rapid speed of onset,” Edward J. Holland, MD, a key advisor on COMET-2 and COMET-3 and senior scientific advisor at Alcon, said in the release. “AR-15512 demonstrated this important achievement in both pivotal efficacy and safety studies, and it represents a first-in-class candidate for chronic dry eye.”
Alcon plans to file a new drug application for AR-15512 with the FDA later this year.
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