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Shire submits new drug application for lifitegrast

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Shire submitted a new drug application with the FDA for the approval of its investigational compound lifitegrast for the treatment of dry eye disease in adults, according to a press release.

The submission is based on results from four clinical trials, which included one phase 2 study, two phase 3 efficacy and safety studies, and one long-term phase 3 safety study, the release said. More than 1,800 subjects were involved in the studies.

“Lifitegrast has potential to be the first treatment indicated to address both the signs and symptoms of dry eye disease,” Philip J. Vickers, PhD, head of research and development at Shire, said in the release.