Xiidra® clinical trial safety1*

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

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Ken Jeong
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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

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.

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.