Eyeworld

SUMMER 2025

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

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© 2025 Tarsus Pharmaceuticals, Inc. All rights reserved. Tarsus, XDEMVY, and the associated logos are registered trademarks of Tarsus Pharmaceuticals, Inc. US--2500213 5/25 As many as ~25 million eye care patients in the United States may have Demodex blepharitis (DB) 2 *STUDY DESIGN: A retrospective chart review for DB by 7 investigators at 6 eye care clinics of the case records of patients (N=1032) who underwent a slit lamp examination, regardless of chief complaint. DB affects ~58% of eye care patients 3, * Might vs mites XDEMVY's taking them down 1 References: 1. XDEMVY [prescribing information]. Tarsus Pharmaceuticals, Inc; 2023. 2. O'Dell L, Dierker DS, Devries DK, et al. Psychosocial impact of Demodex blepharitis. Clin Ophthalmol. 2022;16:2979-2987. 3.Trattler W, Karpecki P, Rapoport Y, et al. The prevalence of Demodex blepharitis in US eye care clinic patients as determined by collarettes: a pathognomonic sign. Clin Ophthalmol. 2022;16:1153-1164. 4. Yeu E, Wirta DL, Karpecki P, Baba SN, Holdbrook M; Saturn I Study Group. Lotilaner ophthalmic solution, 0.25%, for the treatment of Demodex blepharitis: results of a prospective, randomized, vehicle-controlled, double-masked, pivotal trial (Saturn-1). Cornea. 2022;42:435-443. 5. Gaddie IB, Donnenfeld ED, Karpecki P, et al; Saturn-2 Study Group. Lotilaner ophthalmic solution 0.25% for Demodex blepharitis: randomized, vehicle-controlled, multicenter, phase 3 trial (Saturn-2). Ophthalmology. 2023;130(10):1015-1023. Two-thirds of blepharitis cases are associated with Demodex mites 3 The safety and efficacy of XDEMVY for the treatment of DB were evaluated in a total of 833 patients (415 of which received XDEMVY) in two 6-week, randomized, multicenter, double-masked, vehicle-controlled studies (SATURN-1 and SATURN-2). Patients with DB were randomized to either XDEMVY or vehicle at a 1:1 ratio dosed twice daily in each eye. Efficacy was demonstrated by improvement in lids (redution of collarettes to no more than 2 collarettes per upper lid) in each study (SATURN-1 and SATURN-2) by Day 43. 1 Collarettes reduced, mites eradicated, erythema cured 1 In just 6 weeks † : † 1 drop in each eye twice a day. INDICATIONS AND USAGE XDEMV Y (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. To report SUSPECTED ADVERSE REACTIONS, contact Tarsus Pharmaceuticals, Inc. at 1-888-421-4002 or the FDA at 1-800-FDA-1088 (www.fda.gov/medwatch). Please see next page for a Brief Summary of the full Prescribing Information. Learn more at XDEMVYHCP.com Proportion of patients achieving endpoint Collarette Reduction ≤2 Mite Eradication Erythema Cure Collarette Reduction ≤10 17% 68% 7% 19% 23% 81% 7% 44% P<0.01 P<0.01 P<0.01 Vehicle XDEMVY SATURN-1 Clinical Trial Results 1,4 Proportion of patients achieving endpoint Collarette Reduction ≤2 Mite Eradication Erythema Cure Collarette Reduction ≤10 14% 50% 9% 30% 33% 89% 12% 55% P<0.01 P<0.01 P<0.01 Vehicle XDEMVY SATURN-2 Clinical Trial Results 1,5

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