In 3 of the 4 studies, a larger reduction in ICSS favoring Xiidra was observed at 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 Signs were assessed based on Inferior Corneal Staining Score (ICSS) on a scale of 0 to 4 in increments of 0.5. Results were reported as change from baseline at each visit.1
At 12 weeks, Xiidra reduced inferior corneal staining, as measured by the change in ICSS, compared to vehicle in 3 of the 4 studies (Studies 1, 2, and 4).1
Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in ICSS1
Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in ICSS1
Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in ICSS1
Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in ICSS1
*All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 2, one vehicle-treated subject who did not have a study eye designated was excluded from analysis.1
†CI = Confidence Interval
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Indication
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.
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