Full Prescribing Information


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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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.