Eyeworld

by Title Heading Name title Contact Name: email P 86 | EYEWORLD | DECEMBER 2023 Benefits of VPE There are many benefits to using VPE for both patients and practices. For patients, having a clear understanding of treatment reduces anxiety, increases satisfaction with care, and improves pre- and post-care treatment compli- ance, which reduces complications and increases recovery times. It can be especially helpful for patients in remote or rural areas where VPE can provide many of these benefits without multiple trips to the clinic, which can sometimes discourage them from seeking care or following through with treatment plans. For physicians, this can mean less time spent explain- ing procedures. In addition, it makes the practice more efficient, increases patient engagement, and helps improve outcomes through better patient compliance. VPE as a marketing tool VPE can also be used as a highly effective marketing tool for reaching out to potential patients. For example, in- formation or an audio-visual presentation on LASIK or cataract surgery sent to existing patients who are identified as being good candidates can help increase business. This can also help alleviate apprehension and remove possible barriers that could be keeping them from moving forward with care. A practice can send links to its website along with these messages to promote the other services the practice offers. Conclusion VPE is a valuable tool that can help to improve patient satisfaction, promote compliance with treatment plans, and increase business. Patients who are more engaged and a practice that is running more efficiently is a win for all. continued from page 84 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 © 2023 Tarsus Pharmaceuticals, Inc. All rights reserved. XDEMVY is a trademark of Tarsus Pharmaceuticals, Inc. US--2300345 9/23 LESSONS LEARNED Jennifer Loh, MD, Cataract Editorial Board member, shared a lesson she has learned to "level up": I'm not sure if everyone knows about the eyeSpace app, created by Matt Hirabayashi, MD, and Gurpal Virdi, MD. This app lets you look up all of the IOLs (different makes and models) and the powers that they come in. This is so helpful when you have a patient who needs a high or low power lens that is not commonly made.

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