Shire NDA for Dry Eye Drug Approved

FDA has approved a Shire NDA for Xiidra (lifitegrast ophthalmic solution) for treating dry eye disease signs and symptoms. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, according to an agency release.

Approval was based on data from over 1,000 patients involved in four separate, randomized, controlled studies. FDA says patients were randomized equally to receive either Xiidra eyedrops or placebo eyedrops, which were used twice a day for 12 weeks. Data from the studies showed that those treated with Xiidra demonstrated more improvement in both the signs and the symptoms of eye dryness than the groups treated with placebo, it says. The most common side effects experienced by those taking Xiidra include eye irritation, discomfort or blurred vision and an unusual taste sensation (dysgeusia).