JUN/JUL 2020

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: http://digital.eyeworld.org/i/1261109

Contents of this Issue


Page 57 of 58

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. Please see Brief Summary of Prescribing Information on adjacent page. Novartis Pharmaceuticals Corporation One Health Plaza East Hanover, New Jersey 07936-1080 © 2020 Novartis 5/20 XIA-1388813 References: 1. U.S. Food and Drug Administration. Code of Federal Regulations, Title 21, Volume 5 (21CFR349). https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=349&showFR=1. Accessed April 17, 2020. 2. Jones L, Downie LE, Korb D, et al. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017;15(3):575-628. 3. Xiidra [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; November 2019. SHE MAY NEED MORE THAN ARTIFICIAL TEARS TO DISRUPT INFLAMMATION IN DRY EYE DISEASE 1,2 Her eyes deserve a change. *In some patients with continued daily use. One drop in each eye, twice daily (approximately 12 hours apart). † Xiidra is an LFA-1 antagonist for the treatment of dry eye disease. 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 endpoints included assessment of signs (based on Inferior fluorescein Corneal Staining Score [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 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. Effects on signs of dry eye disease ICSS (on a scale from 0-4; 0=no staining; 4=coalescent) was recorded at each study visit. At day 84, a larger reduction in inferior corneal staining favoring Xiidra was observed in 3 of the 4 studies. 3 Choose twice-daily Xiidra for lasting relief that can start as early as 2 weeks. 3 * †

Articles in this issue

Links on this page

Archives of this issue

view archives of Eyeworld - JUN/JUL 2020