FDA Rejects Shire Blockbuster Hopeful Eye Drug

Oct 21, 2015

Market Watch

The U.S. FDA declined to approve Shire's new eye drug lifitegrast, requesting an additional clinical study.

Shire CEO Flemming Ornskov said he was "disappointed" with the FDA's response but that the company would soon have data from an additional study and could still launch the drug in 2016.

Lifitegrast, which Shire acquired in early 2013 when it bought SARcode Bioscience, treats chronic dry eye syndrome, a condition that causes patients to suffer from blurred vision and a burning sensation in the eyes. Shire, however, has been unable to prove that the drug treats both the signs and symptoms of dry-eye disease in a single clinical study.

Read the Market Watch release