FDA Approves Shire’s Xiidra

Xiidra is the only treatment Indicated for the signs and symptoms of dry eye disease.

“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 Flemming Ornskov, Shire. “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. 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.”

An estimated 16 million adults in the US are diagnosed with dry eye disease. An often chronic ocular disease, dry eye 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.

“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,” said Edward Holland, Professor of Clinical Ophthalmology, University of Cincinnati and a clinical trial investigator for Xiidra. “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.”

“Dry eye is a common complaint to eye care professionals, with millions of US adults experiencing the symptoms of this often chronic disease,” said Kelly K. Nichols, Dean of the University of Alabama at Birmingham School of Optometry. “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.”