FDA to Review Lifitegrast for Dry Eye Disease

Shire announced that it has submitted a New Drug Application (NDA) to the FDA for its investigational compound lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.

The NDA submission is supported by data from four clinical trials with more than 1,800 patients. These included one Phase 2 study, two Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study. 

RELATED: Ophthalmic Treatments for DME Compared in NIH-Funded Study

Lifitegrast is a novel small-molecule integrin inhibitor. It 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. LFA-1/ICAM-1 interaction contributes to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.

For more information call (800) 536-7878 or visit Shire.com.

Loading links....