Say hello to Xiidra® (lifitegrast ophthalmic solution) 5%

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

HOW TO READ A FOREST PLOT

1 The dot represents the mean treatment difference

2 The horizontal bar through the dot represents the confidence interval—in this case, 95%

3 The line at zero is the “null” or “no effect” line

A plot in which the entire range of data stays to the left of the Y-axis shows that the treatment effect can confidently beattributed to Xiidra, rather than to random chance.

The plot shown uses sample data.

STUDY 1 STUDY 2 STUDY 3 STUDY 4

STUDY 1

Treatment Difference (Xiidra – Vehicle) in ICSS¹

Mean Change (SD) From Baseline in ICSS¹

XIIDRA (n=58)	VEHICLE (n=58)
BASELINE 1.77 (0.515)	BASELINE 1.65 (0.513)
WEEK 2 0.06 (0.522)	WEEK 2 0.24 (0.709)
WEEK 6 0.08 (0.591)	WEEK 6 0.19 (0.694)
WEEK 12 0.04 (0.745)	WEEK 12 0.38 (0.785)

STUDY 1 STUDY 2 STUDY 3 STUDY 4

STUDY 2

Treatment Difference (Xiidra – Vehicle) in ICSS¹

Mean Change (SD) From Baseline in ICSS¹

XIIDRA (n=293)	VEHICLE (n=295)
BASELINE 1.84 (0.597)	BASELINE 1.81 (0.599)
WEEK 2 0.04 (0.734)	WEEK 2 0.08 (0.771)
WEEK 6 -0.14 (0.861)	WEEK 6 -0.02 (0.893)
WEEK 12 -0.07 (0.868)	WEEK 12 0.17 (0.819)

STUDY 1 STUDY 2 STUDY 3 STUDY 4

STUDY 3

Treatment Difference (Xiidra – Vehicle) in ICSS¹

Mean Change (SD) From Baseline in ICSS¹

XIIDRA (n=358)	VEHICLE (n=360)
BASELINE 2.39 (0.763)	BASELINE 2.40 (0.722)
WEEK 2 -0.48 (0.802)	WEEK 2 -0.48 (0.798)
WEEK 6 -0.69 (0.918)	WEEK 6 -0.60 (0.899)
WEEK 12 -0.73 (0.926)	WEEK 12 -0.71 (0.943)

STUDY 1 STUDY 2 STUDY 3 STUDY 4

STUDY 4

Treatment Difference (Xiidra – Vehicle) in ICSS¹

Mean Change (SD) From Baseline in ICSS¹

XIIDRA (n=355)	VEHICLE (n=356)
BASELINE 2.46 (0.681)	BASELINE 2.46 (0.746)
WEEK 2 -0.49 (0.914)	WEEK 2 -0.44 (0.775)
WEEK 6 -0.69 (0.941)	WEEK 6 -0.66 (0.927)
WEEK 12 -0.80 (0.939)	WEEK 12 -0.63 (0.911)

^*Based on ANCOVA model adjusted for baseline value and randomization stratification factors. 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 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

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.

Please click here for Full Prescribing Information.

Reference

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

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XIIDRA
REDUCED ICSS¹