XIIDRA WAS WELL
TOLERATED IN
CLINICAL TRIALS1*

The majority of treatment-emergent
adverse reactions were mild to moderate in severity
in the 12-month SONATA study2†

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

Label safety data

*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. 170 patients were exposed to Xiidra for approximately 12 months.1

Across 5 clinical studies, the most common adverse
reactions (reported in 5-25% of patients) were
instillation site irritation, dysgeusia, and reduced
visual acuity1

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.2

Artificial tear use was assessed as an exploratory end point.2

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.

Indication

Xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED).

Important Safety Information

Click here for Full Prescribing Information.

References

  1. Xiidra [package insert]. East Hanover,
    NJ: Novartis Pharmaceuticals Corp;

    June 2020.

  2. Donnenfeld ED, Karpecki PM, Majmudar PA,
    et al. Safety of lifitegrast
    ophthalmic solution
    5.0% in patients with dry eye disease: a 1-year,

    multicenter, randomized, placebo-controlled
    study. Cornea.
    2016;35(6):741-748.