July 13, 2016 — The U.S. Food and Drug Administration on Tuesday gave the nod to the first of a new class of medications against disease.
(lifitegrast) eyedrops are a newly developed type of drug called LFA-1 agonists, the agency explained in a news release.
“Normal tear production is needed for clear vision and ,” Dr. Edward Cox, who directs the FDA’s Office of Antimicrobial Products, said in the news release. “This approval will provide a new treatment option for patients with disease.”
Many older Americans experience dry eye disease, which the FDA says affects about 5 percent of adults in their 30s, and up to 15 percent of people over the age of 65.CONTINUE READING BELOW
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The issue can become serious. “When severe and left untreated, this condition can lead to pain, ulcers or scars on the part of the eye called the ,” the FDA explained.
Xiidra’s safety and effectiveness was assessed in more than 1,000 adults in four separate . Patients received either Xiidra eyedrops or a eyedrop twice daily for three months. According to the FDA, people taking Xiidra gained more improvement in “both the signs and the symptoms of dryness” compared to those taking the placebo.
Side effects included irritation, blurred and “an unusual taste sensation,” the FDA said. Xiidra is made by Shire US, of Lexington, Mass.