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 first and only non-steroid eye drop specifically indicated to treat 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
use artificial tears at day 90 in the 12-month SONATA
safety study6
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
