A larger reduction in EDS favoring Xiidra was observed in all studies at 6 and 12 weeks1
The safety and efficacy of Xiidra compared to vehicle were studied in 2133 patients in 4 well-controlled, 12-week trials.1
Each of the 4 studies assessed the effect of Xiidra compared to vehicle on the signs and symptoms of Dry Eye Disease.1 Symptoms were assessed based on patient-reported Eye Dryness Score (EDS) on a scale of 0 to 100.1 Results were reported as change from baseline at each visit.1
In 2 of the 4 studies, Xiidra provided greater symptom relief compared to vehicle at 2, 6, and 12 weeks.1
*All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 1, one Xiidra-treated subject who did not have a baseline value was excluded from analysis.1
†CI = Confidence Interval
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Xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED).
Important Safety Information
In clinical trials, the most common adverse reactions reported in 5-25% of patients were instillation site irritation, dysgeusia and reduced visual acuity. Other adverse reactions reported in 1% to 5% of the patients were blurred vision, conjunctival hyperemia, eye irritation, headache, increased lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis.
To avoid the potential for eye injury or contamination of the solution, patients should not touch the tip of the single-use container to their eye or to any surface.
Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.
Safety and efficacy in pediatric patients below the age of 17 years have not been established.