FDA grants priority review to novel dry eye drug

The FDA granted Shire’s request for priority review for lifitegrast, a small-molecule integrin inhibitor under investigation for its potential to treat both the signs and symptoms of dry eye.

“The symptoms of dry eye are one of the most common complaints from patients, yet there remains a tremendous unmet need,” said Stephen C. Pflugfelder, MD, professor of ophthalmology at Baylor College of Medicine. “It’s encouraging to see Shire moving the program for lifitegrast forward.”

The FDA is expected to make a decision on Oct. 25. If approved, the company says it would be the first drug to treat both the signs and symptoms of dry eye disease.

The company says the new drug application is supported by the results of several phase 2 and 3 studies, including more than 1,800 patients.

Lifitegrast binds to the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand ICAM-1 (intercellular adhesion molecule-1). ICAM-1 is over-expressed in corneal and conjunctival tissues in dry eye disease, while LFA-1/ICAM-1 interaction contributes to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.