Efficacy and Safety of Lotilaner Ophthalmic Solution 0.25% in Demodex Blepharitis: A Systematic Review.

Abstract

Description Demodex blepharitis is a chronic eyelid inflammation caused by Demodex mites, which are ubiquitous skin parasites. Lotilaner, a newly United States Food and Drug Administration (FDA)-approved drug, is an antiparasitic agent that selectively inhibits parasite-specific γ-aminobutyric acid chloride channels, inducing spastic paralysis and death of Demodex mites. It is applied as an ophthalmic solution, 0.25%, twice a day for 6 weeks, and it has a long half-life and high lipophilicity, facilitating the penetration of the drug into the eyelash follicles and meibomian glands where the mites reside. This study systematically reviewed 6 clinical trials that compared lotilaner with placebo for Demodex blepharitis. The primary efficacy endpoint was complete collarette cure, defined as collarette grade 0 on the upper lid of the analysis eye. The secondary efficacy endpoint was decreased mite density with mite eradication, defined as 0 mites per lash on the analysis eye at day 42. The results showed that lotilaner treatment was significantly more effective than the control in achieving both endpoints, with a maximum reduction of 94.7% in mite density at day 43. The treatment effect persisted for at least 2 months after the end of treatment. Lotilaner was also safe and well tolerated, with no serious adverse events reported. For primary care providers, this study underscores the importance of recognizing collarettes as a key diagnostic marker for Demodex blepharitis during routine examinations. Lotilaner ophthalmic solution, 0.25%, offers a novel, effective therapy for this condition, enabling earlier intervention and improved outcomes for patients. Further investigation in larger trials is warranted to confirm these findings and refine their clinical application.