Eyeworld

by Title Contact Name: email C Heading Name title OCTOBER 2025 | EYEWORLD BONUS ISSUE | 3 by Sumit "Sam" Garg, MD Chief Medical Editor T he proper management of ocular surface disease (OSD) is a cor- nerstone for successful anterior segment surgery and overall ocular health. For anterior seg- ment eye surgeons, understanding and addressing these conditions is no longer optional—it is essential for optimal surgical outcomes and patient satisfaction. This bonus is- sue of EyeWorld focuses on updates in OSD and the impact this near ubiquitous disease has on our patients. The tear film's contribution to the optical system is fundamental, as an abnormal tear film can cause foreign body sensation, fluctuating vision, contact lens intolerance, poor quality of vision, and critically, inaccurate IOL power calculations. Not being proactive with OSD management can lead to several unanticipated issues in the periopera- tive patient. This includes patient dissatisfaction and often requires additional postop visits to address these issues properly. The ASCRS Preoperative OSD Algorithm has been developed specifically to address this challenge, providing surgeons with a systematic approach to identify and treat ocular surface disorders before surgery. This algorithm is designed to be "easy to follow and easy to integrate into the presurgical evaluation," according to Christopher Starr, MD, and can be adapted to whatever diagnostic tools are available in the clinic. Effective management begins with thorough preoper- ative evaluation. Surgeons should ideally examine cata- ract patients before any drops are instilled, following a systematic approach that includes assessing the tear film, examining the lids and lashes for conditions like Demodex mites, evaluating meibomian gland health and meibum quality, and checking for signs of underlying inflammation. This comprehensive assessment takes approximately 30 seconds but can significantly impact surgical planning and outcomes. Collaboration is crucial. Many anterior segment sur- geons benefit from partnering with dry eye specialists and referring optometrists to establish "a synergistic, co-man- agement relationship." This approach ensures patients receive optimal care from providers with specific expertise in ocular surface disease. Patient education and "buy in" is fundamental to suc- cessful OSD management. Some patients may be initially surprised that ocular surface treatments can delay their Management of ocular surface disease continued on page 8 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 continued on page 6

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