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.

Improvement in signs and symptoms with Xiidra: A prescription dry eye treatment

Improvement in signs and symptoms with Xiidra: A prescription dry eye treatment

Xiidra is the only eye drop indicated to specifially treat both the signs and symptoms of dry eye disease.^3-5 Xiidra improved patient-reported symptoms of eye dryness and signs of Inferior fluorescein Corneal Staining Score (ICSS) in clinical trials. Consider prescribing Xiidra for your appropriate dry eye patients.³

Clinical studies
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. The mean age was 59 years (range, 19-97 years). The majority of patients were female (76%). Use of artificial tears was not allowed during the studies. The study end points included assessment of signs (based on ICSS on a scale of 0 to 4) and symptoms (based on patient-reported Eye Dryness Score [EDS] on a visual analogue scale of 0 to 100).³

Vehicle=placebo.
^*Based on number of participants in the safety population with data at the visit.

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.⁶

Artificial tear use was assessed as an exploratory end point.⁶

After day 14 (visit 3), the use of artificial tears (≤4 times daily) was allowed as needed. The question about artificial tear use (Yes/No) was asked beginning at day 90 (visit 4). Participants with any artificial tear use during the study: vehicle=43/98 (43.9%), Xiidra=64/195 (32.8%).⁶