Phase III study of integrin antagonist for treatment of dry eye shows mixed results.

A Phase III clinical study of a novel integrin beta antagonist (“Lifitegrast”), sponsored by Shire plc (LSE: SHP; NASDAQ: SHPG), has shown that twice-daily 5% dosing met a pre-specified co-primary endpoint for the patient-reported symptom of eye dryness (change in eye dryness score from baseline to week 12) (p-value<0.0001) but did not meet a co-primary endpoint for the sign of inferior corneal staining score (change from baseline to week 12) using fluorescein staining compared with placebo (p value=0.6186). The experimental drug, a small-molecule integrin antagonist, is understood to reduce inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) thereby blocking its activation of intercellular adhesion molecule-1 (ICAM-1) which stimulates T-cell activation and cytokine (protein) release.