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Xiidra clinical trial safety1*

The adverse reactions of Xiidra were evaluated across
5 clinical trials in patients with dry eye disease.

Not an actual patient.

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Ken Jeong

Not an actual patient.

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Xiidra clinical trial safety1*

The adverse reactions of Xiidra were evaluated across 5 clinical trials in patients with dry eye disease.

IN THIS SECTION

IN THIS SECTION

Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients.1

Across 5 clinical studies, the most common adverse
reactions (reported in 5%-25% of patients) were1*:

Instillation-site
irritation

Dysgeusia

Reduced visual
acuity

*In 5 clinical studies of dry eye disease with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received Xiidra). The majority of patients (84%) had up to 3 months of treatment exposure. One hundred-seventy patients were exposed to Xiidra for approximately 12 months.1

SONATA safety study information

The 1-year, multicenter, randomized, prospective, double-masked, placebo-controlled, phase 3 SONATA study evaluated the safety of Xiidra compared to vehicle in 331 adult patients who had a self-reported history of dry eye disease. The most common treatment-emergent adverse reactions (>5%) in either treatment group were instillation-site irritation, instillation-site reaction, reduced visual acuity, dry eye, and dysgeusia. Artificial tear use was assessed as an exploratory end point.2

Most frequent adverse events (>5%) in the 12-month study2†

Xiidra tolerability chart featuring the most common adverse reactions.
Xiidra tolerability chart featuring the most common adverse reactions.

Vehicle=placebo.
†Adverse events occurring in >5% of participants in either treatment group.

‡Percentage value indicates the proportion of participants who experienced each type of adverse event. Values inside bars=number of participants.

Assessment of drop comfort in pivotal studies

The comfort of Xiidra can improve over time

  • Numerical improvement in drop comfort scores were seen in the phase 3 OPUS 1-3 studies from day 14 through day 84 at 3 minutes post instillation3-5§
  • Drop comfort was measured based on patient-reported scores from 0 (very comfortable) to 10 (very uncomfortable)3-6

§The safety and efficacy of Xiidra were assessed in 4 multicenter, randomized, prospective, double-masked, placebo-controlled studies (1 phase 2 study, and 3 phase 3 studies [OPUS-1, OPUS-2, and OPUS-3]). The 4 studies evaluated the safety and efficacy of Xiidra compared to vehicle in 2133 patients. Results from OPUS-1 day 0 did not show drop comfort score improvement at the 3-minute mark compared to baseline. Drop comfort was evaluated at day 0 in the phase 2 study and numerical improvement in drop comfort was seen at the 3-minute mark compared to baseline.3-6

FOOTNOTES

§The safety and efficacy of Xiidra were assessed in 4 multicenter, randomized, prospective, double-masked, placebo-controlled studies (1 phase 2 study, and 3 phase 3 studies [OPUS-1, OPUS-2, and OPUS-3]). The 4 studies evaluated the safety and efficacy of Xiidra compared to vehicle in 2133 patients. Results from OPUS-1 day 0 did not show drop comfort score improvement at the 3-minute mark compared to baseline. Drop comfort was evaluated at day 0 in the phase 2 study and numerical improvement in drop comfort was seen at the 3-minute mark compared to baseline.3-6

eye icon

One drop in each eye, twice daily1
Approximately 12 hours apart.

The Xiidra dosing regimen can fit into your patients' daily routines.

See the steps
See the steps

Indication

Xiidra® (lifitegrast ophthalmic solution) 5% is a prescription eye drop used to treat the signs and symptoms of dry eye disease.

Important Safety Information

  • Do not use Xiidra if you are allergic to any of its ingredients. Seek medical care immediately if you get any symptoms of an allergic reaction.
  • 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 a prescription eye drop used to treat the signs and symptoms of dry eye disease.

Important Safety Information

  • Do not use Xiidra if you are allergic to any of its ingredients. Seek medical care immediately if you get any symptoms of an allergic reaction.
  • 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.