FDA Approves Xiidra For Treatment of Dry Eye

August 3, 2016

On July 12, 2016, the FDA announced its approval of Xiidra (manufactured by Shire US Inc., of Lexington, Massachusetts) for the treatment of signs and symptoms of dry eye disease.

The FDA described Xiidra as the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonists, approved by the FDA for dry eye disease.

The safety and efficacy of Xiidra was assessed in over a thousand patients, in four separate, randomized, controlled studies. These studies included patients 19–97 years of age, of which the majority were female (76 percent). Patients were randomized equally to receive either Xiidra eyedrops or placebo eyedrops, which were used twice a day for twelve weeks. The studies found that groups treated with Xiidra demonstrated more improvement in both the signs and the symptoms of eye dryness than the groups treated with placebo.

The most common side effects of Xiidra include eye irritation, discomfort or blurred vision and an unusual taste sensation (dysgeusia).

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