Shire announced that the FDA has accepted for filing and granted Priority Review designation to the New Drug Application (NDA) for 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: FDA to Review Lifitegrast for Dry Eye Disease
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.
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