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.

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Ken Jeong
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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.

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

*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.

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.

Click here for Full Prescribing Information.