TOLERABIILITY

Xiidra was well-tolerated in clinical trials1

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

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 (5-25%) were instillation site irritation, dysgeusia, and reduced visual acuity1

In the 12-month, multicenter, randomized, double-masked, phase 3 study, the safety of Xiidra compared to vehicle was evaluated in a total of 331 adults with Dry Eye Disease.1,2

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Incidence and severity of most frequent adverse events (>5%) in a 12-month safety study2*

The majority of ocular adverse reactions were considered mild to moderate in the 12-month study.2

Percentage value indicates the proportion of participants who experienced each type of adverse event.

Values inside bars = number of participants

*Adverse events occurring in >5% of participants in either treatment group.

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.

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References

  1. Xiidra [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.

  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.