FDA wants more study on dry dye drug lifitegrast

In response to new drug application, the FDA has requested an additional clinical trial and further information on drug quality for Shire’s dry eye disease drug, lifitegrast.

Shire plans to respond with results from a recently completed randomized, double-masked, phase 3 study evaluating the efficacy and safety of lifitegrast in 711 patients.  If study results are positive, Shire plans to refile the liftegrast submission in the first quarter of 2016, remaining on track for the planned launch next year. 

Lifitegrast’s novel mechanism functions by binding to integrin lymphocyte function-associated antigen-1 (LFA-1) thereby inhibiting the expression of inflammatory cytokines.