FDA Approves First Prescription Treatment for Dry Eye Signs and Symptoms

The FDA has granted approval to Shire’s lifitegrast ophthalmic 5% solution (Xiidra), a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adults.

Notably, Xiidra is the first prescription product to receive FDA approval for this purpose.

“The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the US specifically to treat both the signs and symptoms of the condition,” said Shire CEO Flemming Ornskov, MD, MPH, in a press release.

The FDA based its decision on trial data in which the safety and efficacy of Xiidra evaluated in 1181 adult patients across 4 placebo-controlled, 12-week trials. In all 4 studies, the use of the solution was associated with a greater reduction in dry eye disease symptoms than placebo at 6 and 12 weeks.

Xiidra’s safety and effectiveness in children has not yet been established.

“Dry eye is a common complaint to eye care professionals, with millions of US adults experiencing the symptoms of this often chronic disease,” stated University of Alabama School of Optometry dean Kelly K. Nichols, OD, MPH, PhD, in the press release. “It is critical for eye care professionals to have a dialogue with patients who report symptoms because dry eye can be a progressive ocular surface disease.”

Adverse events reported by trial participants treated with Xiidra include eye irritation, discomfort or blurred vision when the drops are applied to the eyes, and dysgeusia. Those who wear contact lenses should remove them before instilling the solution and wait at least 15 minutes before placing the lenses back into the eyes.

Shire plans to launch Xiidra in the United States in the third quarter of 2016.