XIIDRA WAS WELL
TOLERATED IN
CLINICAL TRIALS^1*

The majority of treatment-emergent
adverse reactions were mild to moderate in severity
in the 12-month SONATA study^2†

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

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.

References

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

June 2020.
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.

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XIIDRA WAS WELL TOLERATED IN CLINICAL TRIALS1*