Lifitegrast: Phase III data
Top-line data from the double-blind, U.S. Phase III OPUS-2 trial in 718 patients with dry eye disease who have used artificial tears within 30 days prior to screening showed that twice-daily 5% lifitegrast met the co-primary endpoint of improving patient-reported eye dryness scores from baseline to week 12 vs. placebo (p<0.0001), but missed the co-primary endpoint of improving inferior corneal staining scores using fluorescein staining from baseline to week 12 vs. placebo (p=0.6186). The most common treatment-emergent adverse events were dysgeusia, instillation site irritation, instillation site reaction and reduced visual acuity. No ocular serious treatment-emergent adverse events were reported. Patients were not allowed to use artificial tears during the trial. ...