A Systematic Review and Meta-Analysis of the Safety and Efficacy of 0.25% Lotilaner Ophthalmic Solution in the Treatment of Demodex Blepharitis.

Demodex blepharitis is marked by an excessive presence of Demodex mites on the eyelids, particularly in the lash follicles. While these microscopic mites are a natural component of the skin microbiota, their overabundance can lead to ocular complications. Symptoms associated with Demodex blepharitis include eyelid itching, inflammation, and ocular irritation. Our objective is to investigate Lotilaner as a potential treatment for Demodex blepharitis, assessing both the safety and efficacy of the ophthalmic formula in managing this disease. We conducted research in Web of Science, PubMed, Cochrane Library, and Scopus up to November 2023. The quality of studies was evaluated using the Cochrane Risk of Bias tool, and it was employed to evaluate the quality of evidence. Our meta-analysis was executed using Review Manager 5.4. We evaluated the safety and efficacy of Lotilaner ophthalmic solution with a concentration of 0.25%. The following outcomes were assessed: clinically meaningful reduction in collarette, collarette cure, composite cure, drop comfort, erythema cure, mite density, and mite eradication. In the case of dichotomous data, we used the risk ratio (RR) with a 95% confidence interval (CI). In our analysis, all included studies, comprising a total of 891 participants, consistently reported clinically meaningful reductions in collarettes. The findings were statistically significant, with Lotilaner demonstrating a substantially higher reduction compared to the vehicle group (RR = 3.09, 95% CI [2.65-3.60]; P-value < 0.0001). Notably, results for Drop Comfort outcomes were nonsignificant, indicating no discernible differences compared to the group that used the vehicle (RR = 1.03, 95% CI [0.98-1.07]; P-value = 0.26). However, both mite density and mite eradication outcomes exhibited significant improvements with Lotilaner in comparison to the vehicle (RR = 2.58, 95% CI [2.25-2.95]; P-value < 0.0001) and (RR = 3.80, 95% CI [2.88-5.01]; P-value < 0.0001). The Lotilaner ophthalmic solution at 0.25% showed superior efficacy over the vehicle in reducing collarettes, achieving complete mite eradication within six weeks, and significantly decreasing erythema in Demodex blepharitis. It demonstrated safety with no reported side effects compared to the vehicle. Direct comparative studies with alternative treatments are recommended for a comprehensive assessment of efficacy and safety.