Shire to Submit New Study Results After Lifitegrast Snub

One week after the FDA turned down Shire’s dry eye disease drug, the company is hoping a new study will prop up its chances for approval. The results could allow the drug to enter the U.S. market next year, offering the first competitor for Allergan’s Restasis.

The company had not yet completed the OPUS-3 trial when it submitted its NDA for Lifitegrast, an integrin inhibitor. The trial met both the primary and secondary endpoints, and the firm believes the data will satisfy FDA’s request for an additional trial.

Shire plans to refile its NDA using the study results in early 2016 and is eyeing applications for other markets.

Shire had been granted priority review in April for the ophthalmic solution, slashing its review time with an Oct. 25 PDUFA date before being denied. In its complete response letter declining Lifitegrast, the FDA had asked for another clinical study and more product quality data.