Shire's dry eye drug lifitegrast granted speedy review
This article was originally published in Scrip
The FDA has granted a priority review to Shire's new drug application for lifitegrast, an investigational treatment for dry eye disease in adults, and has set 25 October as the Prescription Drug User Fee Act action date.
Shares of Shire jumped 4.6%, or $11.36, in mid-afternoon trading on 9 April.
If approved, lifitegrast has the potential to be the first treatment indicated to address both signs and symptoms of dry eye, a multifactorial disease of the tears and ocular surface, which results in symptoms of discomfort, visual disturbance and tear film instability with potential damage to the ocular surface.
Dry eye, an often chronic and progressive ocular disease, is one of the most common complaints to eye care professionals and represents a significant unmet need.
Lifitegrast is a novel small-molecule integrin inhibitor that binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1), which 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, according to Shire.
The company said its NDA for lifitegrast is supported four trials involving more than 1,800 patients, including a Phase II study, two Phase III efficacy and safety studies and one long-term Phase III safety study.