2nd Mar 2015 12:26
SAINT HELIER (Alliance News) - Shire PLC on Monday said it has submitted a New Drug Application or NDA with the US Food and Drug Administration for its investigational compound Lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.
The company noted that the NDA submission is supported by the totality of evidence 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.
Lifitegrast is a novel small-molecule integrin inhibitor. It binds to the integrin LFA-1 or 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 or intercellular adhesion molecule-1.
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.
Shire shares were down 1.2% to 5,209.9479 pence on Monday.
Copyright RTT News/dpa-AFX
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