Rapid and lasting symptom relief
Xiidra significantly reduced symptoms of eye dryness at 2 weeks in 2 of 4 studies, with improvements observed at 6 and 12 weeks in all 4 studies1*†
EDS was rated by patients using a visual analogue scale (0=no discomfort, 100=maximal discomfort) at each study visit
Mean Change From Baseline in EDS in four 12-Week StudiesAverage baseline EDS was 40-70 across all 4 pivotal studies
BL, baseline; WKS, weeks.
‡Indicates statistically significant improvement. In Study 1, Week 6 was a secondary endpoint; Study 3, Week 12 was a co-primary endpoint and Weeks 2 and 6 were ad-hoc endpoints; Study 4, Week 12 was the primary endpoint and Weeks 2 and 6 were secondary endpoints.
Notable improvements in signs of dry eye
In 3 of 4 studies, a larger reduction in ICSS favoring Xiidra was observed at 12 weeks1*†
ICSS 0 to 4 was recorded at each study visit
punctate lesions
countable lesions
numerous to count,
but not coalescent
Mean Change From Baseline in ICSS in FOUR 12-Week Studies Average baseline ICSS was approximately 1.8 in studies 1 and 2, and 2.4 in studies 3 and 4
BL, baseline; WKS, weeks.
‡Indicates statistically significant improvement. In Study 1, Week 12 was a secondary endpoint; Study 2 and 3, Week 12 was a co-primary endpoint; Study 4, Week 12 was an ad-hoc endpoint.
Xiidra is the ONLYnonsteroid anti-inflammatory Rx that can start to deliver dry eye symptom relief in just 2 weeks1
In a multicenter, prospective, open-label study of 100 eyes of 100 patients with preoperative dry eye who were treated with Xiidra and undergoing cataract surgery2
XIIDRA WAS OBSERVED TO PROVIDE DRY EYE SYMPTOM RELIEF
BEFORE AND AFTER CATARACT SURGERY2
XIIDRA WAS WELL TOLERATED
Help patients get started by discussing AEs and the safety profile of Xiidra1,3
PEER PERSPECTIVES
See what experts in eye care have to say about their experience with prescribing Xiidra
AE, adverse event.
*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 (approximately 12 hours apart). Use of artificial tears was not allowed during the studies. The study endpoints included assessment of signs (based on ICSS on a scale of 0-4) and symptoms (based on patient-reported EDS on a visual analogue scale of 0-100).1
†Based on analysis of covariance (ANCOVA) model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 1, one Xiidra-treated subject who did not have a baseline value was excluded from analysis. In Study 2, one vehicle-treated subject who did not have a study eye designated was excluded from analysis.1
Indication and important safety information
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.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for full Prescribing Information for Xiidra.
References
- Xiidra. Prescribing information. Bausch & Lomb Inc.
- Hovanesian J, Epitropoulos A, Donnenfeld ED, Holladay JT. The effect of lifitegrast on refractive accuracy and symptoms in dry eye patients undergoing cataract surgery. Clin Ophthalmol. 2020;14:2709-2716. doi:10.2147/OPTH.S264520
- 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. doi:10.1097/ICO.0000000000000803
Indication and important safety information
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