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SYMPTOM
IIMPROVEMENT

A larger reduction in EDS favoring Xiidra vs vehicle was observed in all 4 studies at 6 and
12 weeks. In 2 of the 4 studies, an improvement in EDS favoring Xiidra was seen at 2 weeks1

Four randomized, double-masked, 12-week studies evaluated the efficacy and safety of Xiidra vs vehicle in subjects with Dry Eye Disease (N=2133). Each of the 4 studies assessed the effect of Xiidra vs vehicle on both the signs and symptoms of Dry Eye at baseline and weeks 2, 6, and 12. Assessment of symptoms was based on change from baseline in patient-reported Eye Dryness Score (EDS), which was evaluated on a 0-100 point scale (0=no discomfort, 100=maximal discomfort). The average baseline EDS was between 40 and 70.1

Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in EDS1

Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in EDS1

Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in EDS1

Mean change (SD) from baseline and Treatment Difference (Xiidra – Vehicle) in EDS1

*Based on ANCOVA model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2 to 4. 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.

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.

Please click here for Full Prescribing Information.

Reference

  1. Xiidra [Prescribing Information]. Lexington, MA: Shire US.