Shire announced that the Food and Drug Administration (FDA) has approved Xiidra (lifitegrast ophthalmic solution) 5% for the treatment of the signs and symptoms of dry eye disease in adults. This is the first ophthalmic solution approved to treat both signs and symptoms of this condition.

Xiidra is a first-in-class lymphocyte function-associated antigen-1 (LFA-1) antagonist. The exact mechanism of action of lifitegrast in dry eye disease is not known. Lifitegrast 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). ICAM-1 may be overexpressed in corneal and conjunctival tissues in dry eye disease. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. 

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Xiidra was evaluated in four placebo-controlled, 12-week trials enrolling 1,181 patients. Patients were randomized to either Xiidra or placebo eye drops twice daily for 12 weeks. Each study assessed the effect of Xiidra on the signs and symptoms of dry eye disease at baseline, Week 2, Week 6, and Week 12. The assessment of symptoms was based on change from baseline in patient reported eye dryness score (EDS); the assessment of signs was based on inferior corneal straining score (ICSS). 

Across all studies, a greater reduction in EDS was seen with Xiidra at Weeks 6 and 12. In two of the studies, an improvement in EDS was seen with Xiidra at Week 2. In three of the studies, a greater reduction in ICSS with Xiidra was seen at Week 12.  Instillation site irritation, dysgeusia, and reduced visual acuity were reported as the most common adverse reactions.

Xiidra 5% will be supplied as a pouch containing 5 single-use containers (0.2mL) in 60-count cartons. It is anticipated to launch in the 3rd quarter of 2016. 

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