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Notable improvements in signs of dry eye disease1

In 3 out of 4 studies, a larger reduction in Inferior fluorescein Corneal Staining Score (ICSS) favoring Xiidra was observed at 12 weeks.1

See more study details below.

Not an actual patient.

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Ken Jeong

Not an actual patient.

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Notable improvements in signs of dry eye disease1

In 3 out of 4 studies, a larger reduction in Inferior fluorescein Corneal Staining Score (ICSS) favoring Xiidra was observed at 12 weeks.1

See more study details below.

IN THIS SECTION

IN THIS SECTION

ICSS

Inferior fluorescein Corneal Staining Score (ICSS)

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

Mean ICSS over 12 weeks1

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

STUDY 1

Mean ICSS over 12 weeks. 11% difference from vehicle at week 12.

Vehicle=placebo.

STUDY 2

Mean ICSS over 12 weeks. 11% difference from vehicle at week 12.

Vehicle=placebo.

STUDY 3

Mean ICSS over 12 weeks. 2% difference from vehicle at week 12.

Vehicle=placebo.

STUDY 4

Mean ICSS over 12 weeks. 9% difference from vehicle at week 12.

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

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How Xiidra works

Xiidra is a nonsteroid therapy that targets a possible underlying cause of dry eye disease.1-4

See the science
See the science

*Xiidra blocks LFA-1 on T cells from binding with ICAM-1 that may be overexpressed on the ocular surface in dry eye disease and may prevent formation of an immunologic synapse which, based on in vitro studies, may inhibit T cell activation, migration of activated T cells to the ocular surface, and reduce cytokine release. The exact mechanism of action of Xiidra in dry eye disease is not known.1,3,4

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for Full Prescribing Information.

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here for Full Prescribing Information.