FDA Approves New Class of Eyedrops to Treat Dry Eye Disease

The FDA recently approved the first lymphocyte function-associated antigen 1 (LFA-1) antagonist, Xiidra (lifitegrast ophthalmic solution), for the treatment of dry eye disease.

Dry eye disease includes conditions where the eyes do not create enough tears or the tears are not of the proper consistency, according to the FDA. Approximately 10 to 15% adults over 65-years-old are affected by the disease.

If untreated, the disease can lead to pain, ulcers, or scars.

Researchers analyzed the safety and efficacy of Xiidra in 4 studies that included more than 1000 adult patients with dry eye disease. Patients either received Xiidra eyedrops or placebo eyedrops twice per day for 12 weeks, according to the FDA.

Researchers discovered that patients using Xiidra eyedrops showed increased improvement in signs and symptoms of eye dryness compared with placebo.

Patients most commonly experienced eye irritation, discomfort, blurred vision, and dysgeusia.

“Normal tear production is needed for clear vision and eye health,” said Edward Cox, MD, 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.”