Shire Reports Phase 3 Trials For Lifitegrast In Dry Eye Disease

Shire presented results from the pivotal Phase III OPUS-2 study evaluating lifitegrast (5.0% ophthalmic solution) in adult patients with dry eye disease at the 2014 American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Boston.

In addition to OPUS-2, the company also presented top-line results from the Phase III SONATA safety study. “These clinical trials are part of a large Phase 3 clinical program with more than 1,600 patients. We look forward to meeting with the FDA to discuss the totality of data for lifitegrast, which will help us determine our path forward,” said Phil Vickers, Head of Research & Development at Shire.

OPUS-2 was a multi-center, randomized, placebo-controlled, double masked, parallel-arm study comparing lifitegrast to placebo in patients with dry eye with a recent history of active artificial tear use. The trial met one of the co-primary endpoints of improvement in dry eye compared to placebo but not the second co-primary endpoint of the sign of inferior corneal staining. The company said the secondary endpoints were only descriptive and consistent in improvement in symptoms and lack of improvement in signs.

Dry eye disease is a multi-factorial disease of the tears and ocular surface that lead to symptoms of discomfort, visual disturbance, and tear film instability that could damage the ocular surface. The condition is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.

Lifitegrast is a small-molecule integrin antagonist designed to treat dry eye disease. The drug is a preservative free topical eye solution believed to reduce inflammation by inhibiting adhesion molecule 1 that influences T-cell activation and cytokine protein release.

Joseph Tauber of the Tauber Eye Center, Kansas City presented the OPUS-2 study results at ASCRS. Tauber said that symptoms of dry eye are common and patients have been seeking relief from dry eye symptoms. “It’s encouraging that potential new treatment options are being developed for dry eye disease, which affects millions of people in the U.S.,” he said.