Shire's Xiidra Gets Advantageous Label Covering Signs, Symptoms Of Dry Eye Disease

By examining the "totality of the data" including a Phase II study, FDA approved drug for both measures of dry eye, despite mixed results in pivotal trials.

The delay caused by receiving a complete response letter in the end enabled Shire PLC'sXiidra (lifitegrast) to get the best possible indication – to treat both the signs and symptoms of dry eye disease.

The drug cleared FDA July 11 as the first drug for that indication, despite an initial submission with mixed data and a complete response letter in October 2015. At that...

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