EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/1536325
by Title ASCRS NEWS Heading Name title Contact Name: email How EyeSustain is leading education efforts in ophthalmology EYESUSTAIN UPDATE 16 | EYEWORLD | SUMMER 2025 XDEMVY® (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use BRIEF SUMMARY OF PRESCRIBING INFORMATION Please see the XDEMVY® package insert for full Prescribing Information. INDICATIONS AND USAGE XDEMVY is indicated for the treatment of Demodex blepharitis. CONTRAINDICATIONS None. 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 Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration. ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XDEMVY was evaluated in 833 patients with Demodex blepharitis in two randomized, double-masked, vehicle- controlled studies (Saturn-1 and Saturn-2) with 42 days of treatment. The most common ocular adverse reaction observed in controlled clinical studies 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. USE IN SPECIFIC POPULATIONS Pregnancy: Risk Summary There are no available data on XDEMVY use in pregnant women to inform any drug associated risk; however, systemic exposure to lotilaner from ocular administration is low. In animal reproduction studies, lotilaner did not produce malformations at clinically relevant doses. Data Animal Data In an oral embryofetal developmental study in pregnant rats dosed during organogenesis from gestation days 6-19, increased post-implantation loss, reduced fetal pup weight, and incomplete skeletal ossification were observed at 50 mg/kg/day (approximately 1390 times the recommended human ophthalmic dose (RHOD) on a body surface area basis) in the presence of maternal toxicity (i.e., decreased body weight and food consumption). A rare malformation of situs inversus of the thoracic and abdominal viscera occurred in 1 fetus from a pregnant rat receiving 50 mg/kg/day; whether this finding was treatment-related could not be excluded. No maternal or embryofetal toxicity was observed at 18 mg/kg/day (approximately 501 times the RHOD on a body surface area basis). In an oral embryofetal development study in pregnant rabbits dosed during organogenesis from gestation days 7-19, no embryofetal toxicity or teratogenic findings were observed at 20 mg/kg/day (approximately 580-times the RHOD on an AUC basis), even in the presence of maternal toxicity (i.e., decreased food consumption and body weight). In an oral two-generation reproductive toxicity study, F0 male and female rats were administered lotilaner at doses up to 40 mg/kg/day for 10 weeks before pairing and during the 2-week pairing period (3 weeks for males). Dosing for F0 females continued through lactation day 22. F1 male and female rats were administered lotilaner at 1 and 5 mg/kg/day post-weaning from day 23 for 10 weeks before pairing and during the 2-week pairing period (3 weeks for males). Dosing for F1 parenteral females continued through lactation day 22. There were no clear adverse effects on the F1 generation, and a slightly lower mean body weight during lactation was noted for F2 pups at 5 mg/kg/day. The no observed adverse effect level (NOAEL) was determined to be 5 mg/kg/day (approximately 139 times the RHOD on a body surface area basis). Lactation: Risk Summary There are no data on the presence of XDEMVY in human milk, the effects on the breastfed infant, or the effects on milk production. However, systemic exposure to lotilaner following 6 weeks of topical ocular administration is low and is >99% plasma protein bound, thus it is not known whether measurable levels of lotilaner would be present in maternal milk following topical ocular administration. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XDEMVY and any potential adverse effects on the breast-fed child from XDEMVY. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of lotilaner. Mutagenesis Lotilaner was not genotoxic in the following assays: Ames assay for bacterial gene mutation, in vitro chromosomal aberration assay in cultured human peripheral blood lymphocytes, and in vivo rat micronucleus test. Impairment of fertility In a two-generation study of reproductive performance in rats, F0 male and female rats were administered lotilaner at oral doses of 40 mg/kg/day for 80 days reduced to 20 mg/kg/day for 47-50 supplementary days. Reduced pregnancy rates and decreased implantation rates were observed in F0 females at doses 20 mg/kg/day) (approximately 556 times the RHOD on a body surface area basis), which were also associated with maternal toxicity (i.e., decreased body weight and food consumption). No effects on fertility were observed in F0 females at the dose of 5 mg/kg/day (approximately 139 times the MRHOD on a body surface area basis). No effects on fertility were observed in F0 males at the oral dose of 20 mg/kg/day (approximately 556 times the RHOD on a body surface area basis), and no effects on fertility were observed in F1 males and females at the oral dose of 5 mg/kg/day (approximately 139 times the RHOD on a body surface area basis). PATIENT COUNSELING INFORMATION Handling the Container Instruct patients to avoid allowing 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. When to Seek Physician Advice Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of XDEMVY. Use with Contact Lenses Advise patients that 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. Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications. Missed Dose Advise patients that if one dose is missed, treatment should continue with the next dose. RX only © 2024 Tarsus Pharmaceuticals, Inc. All rights reserved. XDEMVY is a registered trademark of Tarsus Pharmaceuticals, Inc. US--2300345 1/24 As our commitment to sustainability in eyecare grows, the importance of educating the next generation of physicians is paramount. It is vital that our medical students, residents, and fellows are trained on best practices for waste reduction in our field. With this evolving education toolbox, they will move forward in their careers with the mindset that waste reduction is the rule, not the exception. In this issue's EyeSustain Update column, Barbara Erny, MD, outlines the ongoing efforts to educate trainees in ophthalmology, with commentary from Cynthia Beauchamp, MD, on the ABO's collaboration with EyeSustain. Emily Schehlein, MD EyeSustain Update Guest Editor Building an educational foundation EyeSustain has developed a robust digital platform to dis- seminate knowledge on sustainable practices. The website features comprehensive educational resources, and regu- lar social media updates highlight emerging research and innovations. Students and early-career ophthalmologists contribute by summarizing new studies and providing access to original research papers. The organization recognizes that educating the next generation of practitioners is critical for long-term success. With 65% of U.S. medical schools now including climate and health education in pre-clinical curricula, EyeSustain focuses on extending this knowledge into postgraduate training, where theoretical understanding can transform into clinical application. Integrating sustainability into professional standards Significant progress has been made in incorporating sustainability into formal ophthalmology education. The American Academy of Ophthalmology (AAO) Basic and Clinical Science Course (BCSC) now features a dedicated chapter on sustainable operating room practices in its "Ba- sic Principles of Ophthalmic Surgery" book. This material covers the carbon footprint of cataract surgery, common barriers to implementing eco-friendly practices, and the crucial role of surgeons in advancing sustainability. Further integration appears in the BCSC discussion of health equity, which addresses how pollution levels, housing conditions, and access to clean water—all factors affected by healthcare practices—impact patient outcomes. The manufacturing processes, sterilization techniques,