Lifitegrast: Phase III data

Top-line data from the double-blind, U.S. Phase III OPUS-1 trial in 588 patients with dry eye disease showed that twice-daily 5% lifitegrast met the co-primary endpoint of improving inferior corneal staining scores from baseline to week 12 vs. placebo (p=0.0007). Lifitegrast missed the co-primary endpoint of improving visual-related function score as measured by ODSI score vs. placebo (p=0.7894). On secondary endpoints, lifitegrast significantly improved total corneal staining (p=0.0148), mean ocular discomfort (p=0.0273) and mean eye dryness scores (p=0.0291) from baseline to week 12 vs. placebo. Lifitegrast was well tolerated with no unexpected or serious ocular adverse events reported. The most common ocular adverse events were irritation and pain upon initial instillation of lifitegrast. Data will be presented at the American Academy of Ophthalmology Meeting in Chicago in November. ...