Twice-daily lotilaner ophthalmic solution effective treatment of patients with Demodex blepharitis

Outcome measures included collarette cure (collarette grade 0), clinically meaningful collarette reduction to ≤10 collarettes (grade 0 or 1), mite eradication (0 mites/lash), erythema cure (grade 0), composite cure (grade 0 for collarettes as well as erythema), compliance with the drop regimen, drop comfort, and adverse events.

Results

At Day 43, the study group achieved a statistically significant (p<0.0001) higher proportion of patients with collarette cure (56.0% vs 12.5%), clinically meaningful collarette reduction to ≤10 collarettes (89.1% vs 33.0%), mite eradication (51.8% vs 14.6%), erythema cure (31.1% vs 9.0%), and composite cure (19.2% vs 4.0%) than the control group. High compliance with the drop regimen (mean ± standard deviation: 98.7 ± 5.3%) in the study group was observed, and 90.7% of patients found the drops to be neutral to very comfortable.

Twice-daily treatment with lotilaner ophthalmic solution, 0.25% for 6 weeks was generally safe and well tolerated and met the primary endpoint and all secondary endpoints for the treatment of Demodex blepharitis compared to the vehicle control.

Reference:

Ian Benjamin Gaddie, Eric D. Donnenfeld, Paul Karpecki, John Meyer, Elizabeth Yeu, Saturn II Study Group. Lotilaner Ophthalmic Solution, 0.25% for Demodex Blepharitis: Randomized, Vehicle-Controlled, Multicenter, Phase 3 Trial (Saturn-2). Published:June 05, 2023DOI:https://doi.org/10.1016/j.ophtha.2023.05.030