Dry Eye Drug Under FDA Priority Review
The FDA has granted priority review to Shire's lifitegrast treatment.
The FDA has granted priority review to Shire’s investigational lifitegrast treatment for drug eye disease in adults.
Lifitegrast is a small-molecule integrin inhibitor that binds to a cell surface protein found on leukocytes, blocking its interaction with a molecule that is typically over-expressed in corneal and conjunctive tissues in dry eye disease.
“The symptoms of dry eye are one of the most common complaints from patients, yet there remains a tremendous unmet need,” said Stephen Pflugfelder, professor of ophthalmology at the Baylor College of Medicine, in a press release. “It’s encouraging to see Shire moving the program for lifitegrast forward.”
The drug’s regulatory filing is supported by clinical evidence from 4 phase 2 and 3 efficacy and safety trials that studied more than 1800 patients.
“Our commitment to moving lifitegrast forward reflects our intent to grow in the ophthalmics therapeutic category in areas of unmet patient need,” said Philip Vickers, head of research and development at Shire, in a statement. “We look forward to working closely with the FDA throughout the review process.”
The FDA is expected to decide on lifitegrast on October 25, 2015.