Trials & Filings

Shire Eye Drug Misses Clinical Endpoint

Hits patient-reported dryness endpoint, but corneal staining score comes up short

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

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 f...

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