FDA Approves First of New Class of Drugs for Dry Eye
The U.S. Food and Drug Administration on Tuesday gave the nod to the first of a new class of medications against dry eye disease.
Xiidra (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 eye health,” 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 dry eye 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.
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 cornea,” the FDA explained.
Xiidra’s safety and effectiveness was assessed in more than 1,000 adults in four separate clinical trials. Patients received either Xiidra eyedrops or a placebo eyedrop twice daily for three months. According to the FDA, people taking Xiidra gained more improvement in “both the signs and the symptoms of eye dryness” compared to those taking the placebo.
Side effects included eye irritation, blurred vision and “an unusual taste sensation,” the FDA said. Xiidra is made by Shire US, of Lexington, Mass.