Shire reports mixed results from Phase III study of lifitegrast in dry eye disease

Ireland-headquartered drugmaker Shire (LSE: SHP)has announced mixed results from a Phase III efficacy and safety study of 5.0% lifitegrast ophthalmic solution for dry eye disease.

OPUS-2 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 prespecified co-primary endpoint for the patient-reported symptom of eye dryness (change in Eye Dryness Score from baseline to week 12). However, it 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.

Shire chief executive Flemming Ornskov said: “In this clinical trial, we note that lifitegrast showed a statistically significant improvement in the prespecified symptoms of dry eye disease and is the first drug to do so in a Phase III clinical trial. We will be examining the totality of the data for lifitegrast in OPUS-2, as well as OPUS-1 and across the entire clinical trial program. We look forward to discussing the lifitegrast program with regulatory authorities.”