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Shire’s lifitegrast improves patient-reported symptoms of dry eye in phase 3 trial

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The OPUS-3 phase 3 trial of lifitegrast has met its primary endpoint of improving patient-reported symptoms of dry eye disease, according to topline results released by Shire.

OPUS-3, a phase 3 efficacy and safety study of lifitegrast vs. placebo, met its primary endpoint of significantly improving patient-reported symptoms from baseline to day 84 (P = .0007), according to a company press release. Patient symptoms significantly improved (P < .0001) at days 14 and 42 as well, thus meetings two “key” secondary endpoints and showing symptom improvement as early as 2 weeks from baseline, according to the release.

Flemming Ornskov

“We’re delighted with the positive topline findings from OPUS-3 and look forward to resubmitting to the FDA the new drug application for lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016. If approved by the FDA, this keeps us on track for a potential U.S. launch next year,” Flemming Ornskov, MD, CEO of Shire, said in the release.