Eyeworld

DEC 2023

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

Issue link: https://digital.eyeworld.org/i/1510779

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INDICATIONS AND USAGE XDEMVY (lotilaner ophthalmic solution) 0.25% is indicated for the treatment of Demodex blepharitis. IMPORTANT SAFETY INFORMATION: WARNINGS AND PRECAUTIONS Risk of Contamination: Do not allow the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Use with Contact Lenses: XDEMVY contains potassium sorbate, which may discolor soft contact lenses. Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration. ADVERSE REACTIONS: The most common adverse reaction with XDEMVY was instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum and punctate keratitis. FDA-APPROVED TREATMENT FOR DEMODEX BLEPHARITIS (DB) 44% and 55% of patients taking XDEMVY in SATURN-1 (N=209) and SATURN-2 (N=193), respectively, achieved a significant improvement in their eyelids (reduction of collarettes to no more than 2 collarettes per upper lid) at Day 43 vs 7% (N=204) and 12% (N=200) of patients taking vehicle (P<0.01 in each trial).* All images are of actual patients who participated in clinical trials for Tarsus Pharmaceuticals. * The safety and efficacy of XDEMVY for the treatment of DB were evaluated in a total of 833 patients (415 of whom received XDEMVY) in two 6-week, randomized, multicenter, double-masked, vehicle-controlled studies (SATURN-1 and SATURN-2). Patients were randomized to either XDEMVY or vehicle at a 1:1 ratio, dosed twice daily in each eye for 6 weeks. All patients enrolled were diagnosed with DB. The primary efficacy endpoint was defined as the proportion of patients with collarette reduction to no more than 2 collarettes per upper eyelid at Day 43 (SATURN-1: XDEMVY N=209, vehicle N=204, P<0.01; SATURN-2: XDEMVY N=193, vehicle N=200, P<0.01). © 2023 Tarsus Pharmaceuticals, Inc. All rights reserved. Tarsus, XDEMVY, and the associated logos are trademarks of Tarsus Pharmaceuticals, Inc. US––2300405 9/23 Reference: XDEMVY [prescribing information]. Tarsus Pharmaceuticals, Inc; 2023. Real results NOW AVAILABLE TO PRESCRIBE Please see next page for a Brief Summary of the full Prescribing Information. in just 6 weeks Might over mites AFTER BEFORE Learn more at XDEMVYHCP.com

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