ARTICLE | Company News
FDA wants another lifitegrast trial from Shire
October 20, 2015 1:27 AM UTC
Shire plc (LSE:SHP; NASDAQ:SHPG) received a complete response letter from FDA for an NDA for lifitegrast ( SHP606) to treat dry eye. The agency requested an additional clinical study and product quality information.
The company expects top-line data from the Phase III OPUS-3 study of lifitegrast by YE15. The 711-patient trial's primary endpoint is patient-reported symptom improvement measured by eye dryness scores. Shire said if the data are positive, it plans to resubmit the NDA in 1Q16. ...