FDA Issues Approval for Xiidra Eyedrops to Treat Dry Eye Disease

Dry eye disease affects about 10 to 15 percent of adults over age 65

FDA Issues Approval for Xiidra Eyedrops to Treat Dry Eye Disease
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July 12, 2016

The Food and Drug Administration (FDA) has approved a new treatment for individuals suffering from dry eye disease.

The agency's approval is for Xiidra, the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist. The product is manufactured by Shire US Inc.

"Normal tear production is needed for clear vision and eye health," said Edward Cox, in a written statement. Cox is the director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "This approval will provide a new treatment option for patients with dry eye disease."

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. When severe and left untreated, this condition can lead to pain, ulcers or scars on the part of the eye called the cornea.

The chance of experiencing dry eye increases with age, affecting approximately five percent of the adult population age 30-40 and 10 to 15 percent of adults over age 65, and is more common among women.

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).