FDA Says ‘Yes’ to Lifitegrast (Xiidra) Ophthalmic Solution for Dry Eye Disease

First LFA-1 agonist approved for this indication

The FDA has given the green light to Xiidra (lifitegrast ophthalmic solution, Shire US Inc.) for the treatment of the signs and symptoms of dry eye disease. Xiidra is the first medication in a new class of drugs called lymphocyte function-associated antigen 1 (LFA-1) agonists to be approved by the FDA for this indication.

Dry eye disease includes a group of conditions in which the eye does not produce an adequate volume of tears or when the tears are not of the correct consistency. The chance of experiencing dry eye increases with age, affecting approximately 5% of the adult population 30 to 40 years of age and 10% to 15% of adults over the age of 65, and is more common among women. When severe and left untreated, the condition can lead to eye pain and ulcers or scars on the cornea.

The safety and efficacy of Xiidra were assessed in more than 1,000 patients in four randomized, controlled studies. These trials included patients 19 to 97 years of age, most of whom were female (76%). The patients were randomly assigned to receive either Xiidra eye drops or placebo eye drops, which were used twice a day for 12 weeks. The groups treated with Xiidra demonstrated more improvement in both the signs and the symptoms of eye dryness compared with the groups treated with placebo.

The most common adverse events associated with Xiidra included eye irritation, eye discomfort, blurred vision, and dysgeusia.

Dry eye disease does not routinely occur in children. The safety and efficacy of Xiidra in pediatric patients younger than 17 years of age have not been studied.

Source: FDA(link is external); July 12, 2016.

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