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Xiidra may provide lasting symptom relief in as early as 2 weeks1

Xiidra reduced symptoms of eye dryness (based on EDS) at 2 weeks in 2 out of 4 studies, with improvements observed at 6 and 12 weeks in all 4 studies.1

Xiidra is indicated for the treatment of signs and symptoms of dry eye disease.1

See more study details below.

Not an actual patient.

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Ken Jeong

Not an actual patient.

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Xiidra may provide lasting symptom relief in as early as 2 weeks1

Xiidra reduced symptoms of eye dryness (based on EDS) at 2 weeks in 2 out of 4 studies, with improvements observed at 6 and 12 weeks in all 4 studies.1

Xiidra is indicated for the treatment of signs and symptoms of dry eye disease.1

See more study details below

IN THIS SECTION

IN THIS SECTION

EDS scale from
0 to 100

Dry eye scale

EDS was rated by patients using a visual analogue scale (0=no discomfort, 100=maximal discomfort)
at each study visit.

Across all 4 Xiidra pivotal studies, average baseline EDS was 40-70.1

Study1 Study1
Study2 Study2
Study3 Study3
Study4 Study4

Based on analysis of covariance (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 1, one Xiidra-treated subject who did not have a baseline value 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 EDS on a visual analogue scale of 0 to 100).1

eye icon

The signs of dry eye disease

Xiidra was evaluated for its impact on the signs of dry eye disease in 4 robust clinical trials.1

See the study results
See the study results

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.