Lifitegrast misses prespecified co-primary endpoint

Dublin, Ireland-Shire has announced the results from OPUS-2, a phase III efficacy and safety study of its treatment of dry eye, 5.0% lifitegrast ophthalmic solution.

The study compared the drug with a placebo administered twice daily for 84 days in dry eye patients with a 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 (p < 0.0001). However, the drug did not meet the prespecified co-primary endpoint for the sign of inferior corneal staining score using fluorescein staining, compared with the placebo (p = 0.6186).

“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,” said Flemming Ornskov, MD, chief executive officer of Shire. “We will be examining the totality of the data for (the drug) in OPUS-2, as well as OPUS-1 and across the entire clinical program. We look forward to discussing the lifitegrast program with regulatory authorities.”

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