LEXINGTON, Mass. — Shire plc has received Food and Drug Administration approval for Xiidra 5% (lifitegrast ophthalmic solution), a twice-daily eye drop solution for dry eye.
Plans call for Xiidra to launch in the United States in the third quarter. Shire said the product represents the only prescription eye drop indicated for the treatment of both signs and symptoms of dry eye disease for adults in the U.S.
“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 U.S. specifically to treat both the signs and symptoms of the condition,” stated Shire chief executive officer Flemming Ornskov.
“As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs,” he added. “We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entrée into the space as we continue to develop additional innovative eye care treatment options.”
According to Shire, an estimated 16 million U.S. adults are diagnosed with dry eye disease. The condition, an often chronic ocular disease, is associated with inflammation that may eventually lead to damage to the surface of the eye. An eye care professional can diagnose dry eye disease based on signs and symptoms and determine management options, which could include the use of a prescription treatment. Xiidra is dosed twice per day, approximately 12 hours apart, in each eye.
“The clinical program supporting the approval of Xiidra is the largest for an investigational-stage dry eye disease candidate to date, including more than 2,500 patients,” commented Xiidra clinical trial investigator Edward Holland, M.D., a professor of clinical ophthalmology at the University of Cincinnati. “The clinical trial program design took into consideration many of the challenges of past dry eye research. It’s exciting to see Xiidra as the first prescription eye drop FDA-approved for both the signs and symptoms of the condition.”