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Phase III safety data for lifitegrast treatment of adult dry eye disease released by Shire

Summary data from a US-based double-blind placebo controlled phase III study has reported no ocular or treatment-related serious adverse events for lifitegrast in the treatment of dry eye. The drug, a small-molecule integrin antagonist in a topical eye solution, is understood to reduce inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) which blocks binding to intercellular adhesion molecule-1 (ICAM-1) impacting on T-cell activation and cytokine release. LFA-1 CAM-1 interaction is understood to play a key role in the chronic inflammation associated with dry eye. The sponsor of the study, Shire plc., additionally announced the launch of a new ophthalmology business unit to commercialise the pipeline of ocular products under development. Shire now plans to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in Q1 2015.