Phase 3 Study Update of Lifitegrast for Dry Eye
SARcode Bioscience announced topline results from OPUS-1, a pivotal Phase 3 study of lifitegrast ophthalmic solution, 5%, vs. placebo for the treatment of dry eye disease.
OPUS-1 was a prospective, randomized, double-masked study that evaluated the efficacy and safety of lifitegrast ophthalmic solution, 5%, compared to placebo for the treatment of signs and symptoms of dry eye disease. The study included 588 subjects with dry eye disease from 13 sites in the US. Subjects received lifitegrast or placebo dosed two times a day for 12 weeks.
In the study, lifitegrast demonstrated superiority over placebo in the improvement of inferior and total corneal staining scores from baseline to Week 12 (P=0.0007 and P=0.0148, respectively). Ocular surface damage, which is a hallmark of chronic inflammation from dry eye disease, is often detected using these staining parameters.
Lifitegrast also significantly improved the most commonly reported symptoms of dry eye disease in the study, which were ocular discomfort and eye dryness. The mean ocular discomfort score and mean eye dryness score were lower in the lifitegrast group than in the placebo group at Week 12 (P=0.0273 and P=0.0291, respectively).
Lifitegrast is an investigational novel small-molecule integrin antagonist.
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