Phase 3 study of new dry eye treatment shows promising top-line results
Top-line results from OPUS-2, a phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution, describe statistically significant improvement in patient-reported dry eye symptoms, according to a Shire press release.
At week 12, lifitegrast met the co-primary endpoint for change in Eye Dryness Score at 12 weeks, but did not meet the other primary endpoint for change in sign of inferior corneal staining score using fluorescein staining compared with placebo, according to the release.
Lifitegrast is a small-molecule integrin antagonist and a preservative-free topical eye solution designed to treat dry eye disease.
OPUS-2 is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study comparing 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 before screening, the release said.
There were no serious ocular adverse events reported, and the most commonly reported treatment-emergent adverse events were dysgeusia, instillation site irritation, instillation site reaction and reduced visual acuity, according to the release.
Further study of lifitegrast was initiated in the SONATA trial, a prospective, randomized, double-masked, placebo-controlled trial in 300 dry eye subjects intended to evaluate the safety of lifitegrast for 1 year. SONATA is scheduled for completion in mid-2014, according to the release.