Lifitegrast regulatory update

FDA issued a complete response letter to Shire for an NDA for lifitegrast to treat signs and symptoms of dry eye disease in adults. The agency requested an additional clinical study and product quality information. The company expects top-line data from the Phase III OPUS-3 trial of lifitegrast by year end. Shire said if the data are positive, it plans to resubmit the NDA in 1Q16. ...