Gil Roth12.06.13
Shire has posted top-line results from OPUS-2, a Phase III efficacy and safety study of 5.0% lifitegrast ophthalmic solution. The trial compared lifitegrast to placebo administered twice daily for 84 days (12 weeks) in dry eye patients with history of active artificial tear use within 30 days prior to screening. Lifitegrast met the co-primary endpoint for the patient-reported symptom of eye dryness (change in Eye Dryness Score from baseline to week 12), but did not meet the co-primary endpoint for the sign of inferior corneal staining score (change from baseline to Week 12) using fluorescein staining compared with placebo.
The study also evaluated the safety and tolerability of lifitegrast based on occurrence of treatment-emergent adverse events (TEAEs). The most commonly reported TEAEs associated with lifitegrast were dysgeusia (altered sense of taste) (16.2% vs 0.3% for placebo), instillation site irritation (7.8% vs 1.4% for placebo), instillation site reaction (7.0% vs 1.1% for placebo) and visual acuity reduced (5.0% vs 6.4% for placebo). There were no ocular serious TEAEs or drug-related serious TEAEs. 93.2% of patients enrolled in the study remained for the entire duration of the 12-week clinical trial.
OPUS-2 was a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, with a 14-day open-label placebo screening run-in period. Patients randomized into the study were not allowed to use artificial tears during the study. Overall, 718 patients were randomized at 31 US sites. The study consisted of five visits over 98 days.
The study also evaluated the safety and tolerability of lifitegrast based on occurrence of treatment-emergent adverse events (TEAEs). The most commonly reported TEAEs associated with lifitegrast were dysgeusia (altered sense of taste) (16.2% vs 0.3% for placebo), instillation site irritation (7.8% vs 1.4% for placebo), instillation site reaction (7.0% vs 1.1% for placebo) and visual acuity reduced (5.0% vs 6.4% for placebo). There were no ocular serious TEAEs or drug-related serious TEAEs. 93.2% of patients enrolled in the study remained for the entire duration of the 12-week clinical trial.
OPUS-2 was a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, with a 14-day open-label placebo screening run-in period. Patients randomized into the study were not allowed to use artificial tears during the study. Overall, 718 patients were randomized at 31 US sites. The study consisted of five visits over 98 days.