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Full Prescribing Information

Indication

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

Important Safety Information

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

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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.

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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.

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Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration.

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Safety and efficacy in pediatric patients below the age of 17 years have not been established.

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†Pivotal trial data

The safety and efficacy of Xiidra were assessed in four 12-week, randomized, multicenter, double‑masked, vehicle‑controlled studies (N=2133). Patients were dosed twice daily. Use of artificial tears was not allowed during the studies. The study end points included assessment of signs (based on Inferior fluorescein Corneal Staining Score [ICSS] on a scale of 0-4) and symptoms (based on patient‑reported Eye Dryness Score [EDS] on a visual analogue scale of 0-100). 1

Effects on symptoms of dry eye disease: A larger reduction in EDS favoring Xiidra was observed in all studies at day 42 and day 84. Xiidra reduced symptoms of eye dryness at 2 weeks (based on EDS) compared to vehicle in 2 out of 4 clinical trials. 1

Effects on signs of dry eye disease: At day 84, larger reduction in ICSS favoring Xiidra was observed in 3 of the 4 studies.1

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

XIIDRA, the XIIDRA logo and ii are registered trademarks of Novartis AG.