Treatment of Demodex Blepharitis with Lotilaner Ophthalmic Solution, 0.25%: Combined Analysis of Two Pivotal Randomized, Vehicle-Controlled, Multicenter Trials

Abstract

Purpose : The purpose of these two pivotal trials was to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25% (Tarsus Pharmaceuticals) for the treatment of Demodex blepharitis.

Methods : The combined analysis of these two randomized, controlled, double-masked study included 833 subjects with >10 upper lid lashes with collarettes, mild or worse upper lid margin erythema, and ≥1.5 mites/lash on upper/lower lids combined in at least one eye. Subjects administered 1 drop of lotilaner or vehicle in each eye BID for 43 days. The primary endpoint was complete collarette cure (≤2 collarettes) for the upper lid of the analysis eye at day 43 (D43). Eradication of Demodex mites, erythema/collarette composite cure, and erythema cure were also collected. Clinically meaningful collarette cure (defined as ≤10 collarettes) for the upper lid of the analysis eye was also collected.

Results : Complete collarette cure was achieved in 50% of the treatment group vs 10% in the vehicle group at D43 (p<0.0001). Clinically meaningful collarette cure at D43 was observed in 85% and 28% of the treatment and vehicle groups, respectively (p<0.0001). Mite eradication was seen in 60% vs 16% of the treatment and vehicle groups, respectively at D43 (p<0.0001). By D43, erythema cure was observed in 25% of the treatment group vs 8% of the vehicle group (p<0.001), and composite erythema/collarette cure also showed a statistically significant difference (p<0.0001). More than 90% of the patients reported the drop to be neutral to very comfortable. Instillation site pain/burning/stinging was the most frequently reported treatment-emergent ocular adverse event.

Conclusions : Results of the combined analysis of two pivotal trials demonstrated that lotilaner ophthalmic solution, 0.25% met the primary and all secondary endpoints with well-tolerated safety profile.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.