NOTABLE IMPROVEMENTS
IN SIGNS OF
DRY EYE DISEASE¹

In 3 out of 4 studies, a larger reduction in ICSS favoring Xiidra was observed at 12 weeks¹

See more study details below

ICSS 0 to 4 was recorded at each study visit. The average baseline ICSS was approximately 1.8 in Studies 1 and 2, and 2.4 in Studies 3 and 4.¹

STUDY 1 STUDY 2 STUDY 3 STUDY 4

Mean ICSS over 12 weeks¹

Scale has been inverted. Lowering of ICSS from baseline indicates an improvement.

STUDY 1 STUDY 2 STUDY 3 STUDY 4

Vehicle=placebo.

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

The safety and efficacy of Xiidra were assessed in four 12-week, randomized, multicenter, double-masked, vehicle-controlled studies (N=2133). Patients were dosed twice daily. The mean age was 59 years (range, 19-97 years). The majority of patients were female (76%). Use of artificial tears was not allowed during the studies. The study end points included assessment of signs (based on Inferior fluorescein Corneal Staining Score [ICSS] on a scale of 0 to 4) and symptoms (based on patient-reported Eye Dryness Score [EDS] on a visual analogue scale of 0 to 100).¹

Indication

Xiidra^® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED).

Important Safety Information

Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients.
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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NOTABLE IMPROVEMENTS IN SIGNS OF DRY EYE DISEASE1

Mean ICSS over 12 weeks1

Indication

Important Safety Information

Reference

NOTABLE IMPROVEMENTS
IN SIGNS OF
DRY EYE DISEASE¹

Mean ICSS over 12 weeks¹