FDA Approves New Drug for Dry Eye Disease


On July 11, the FDA approved Shire’s Xiidra (lifitegrast ophthalmic solution) 5%, a prescription eye drop solution indicated for the signs and symptoms of dry eye disease (DED) in adults. Xiidra is the only prescription eye drop indicated for the treatment of both the signs and symptoms of this condition, and it is the first treatment to be approved for DED in more than a decade, Shire reports. The company expects to launch the product in the United States in the third quarter of 2016. 

Xiidra is dosed twice per day, approximately 12 hours apart, in each eye. The safety and efficacy of the drug was studied in 1,181 patients (1,067 of whom received lifitegrast 5%) in four placebo-controlled, 12-week trials.

Assessment of symptoms was based on change from baseline in patient-reported eye dryness score (0-100 visual analogue scale). Assessment of signs was based on inferior corneal staining score (0-4 scale). In all four studies, a larger reduction in eye dryness score was observed with Xiidra at 6 and 12 weeks. In two of the four studies, an improvement in eye dryness score was seen with Xiidra at 2 weeks. At week 12, a larger reduction in inferior corneal staining score favoring Xiidra was observed in three of the four studies. The most common adverse reactions reported in 5% to 25% of patients were instillation site irritation, altered taste sensation (dysgeusia), and reduced visual acuity.

The inflammation associated with DED is thought to be primarily mediated by T cells and associated cytokines, reported Shire. One effect of this process may be increased expression of intracellular adhesion molecule-1 (ICAM-1), which may be overexpressed in corneal and conjunctival tissues in DED. Lifitegrast is a small-molecule integrin antagonist that 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 ICAM-1. The interaction of LFA-1 and ICAM-1 can contribute to the formation of an immunological synapse, resulting in T-cell activation and migration to target tissues. According to Shire, 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 mediators (cytokines) in human peripheral blood mononuclear cells. The drug’s exact mechanism of action in DED is not known.


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