Lifitegrast Effective for Dry Eyes in Trials

Shire announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution for dry eyes.

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Lifitegrast, a small-molecule integrin antagonist, was designed to treat dry eye disease. Lifitegrast is believed to work by reducing inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation and cytokine (protein) release.

OPUS-2 was a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study with a 14-day open-label placebo screening run-in period.  The study was designed to compare lifitegrast to placebo administered twice daily for 84 days (12 weeks) in 718 dry eye patients with history of active artificial tear use within 30 days prior to screening.

In the OPUS-2 study, lifitegrast met the prespecified co-primary endpoint for the patient-reported symptom of eye dryness (change in Eye Dryness Score from baseline to week 12) (P<0.0001). Lifitegrast did not meet the prespecified co-primary endpoint for the sign of inferior corneal staining score (change from baseline to Week 12) using fluorescein staining compared with placebo (P=0.6186).

The Phase 3 clinical development program for lifitegrast consists of the OPUS-1, OPUS-2, and SONATA trials. The SONATA trial is scheduled for completion in mid 2014.

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