OR WAIT null SECS
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.
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.”
For more articles in this issue of Ophthalmology Times eReport, click here.
To receive weekly clinical news and updates in ophthalmology, subscribe to the Ophthalmology Times eReport.