FDA approves Shire’s Xiidra

SILVER SPRING, Md. — The Food and Drug Administration has approved Shire’s Xiidra (lifitegrast ophthalmic solution, 5%), the company announced Tuesday. Xiidra is twice-daily eyedrop solution indicated to treat signs and symptoms of dry eye, which affects an estimated 16 million adults in the U.S. The drug is the first approval from Shire’s ophthalmics pipeline

 

“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,” Shire CEO Dr. Flemming Ornskov said. "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.”

 

Shire said it expects Xiidra to be available in the third quarter of 2016.