Shire to resubmit lifitegrast NDA with OPUS-3 data

Shire plc (LSE:SHP; NASDAQ:SHPG) said lifitegrast ( SHP606) met the primary endpoint in the Phase III OPUS-3 trial to treat dry eye, putting the candidate on track for a 1Q16 NDA resubmission and potential 2016 U.S. launch.

Last week, Shire received an FDA complete response letter that requested an additional clinical study and product quality information. Shire plans to include the OPUS-3 data in its resubmission (see BioCentury Extra, Oct. 19). ...