Lotilaner Ophthalmic Solution 0.25% for Demodex Blepharitis

Purpose To evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25% compared to the vehicle for the treatment of Demodex blepharitis. Design Prospective, randomized, double-masked, vehicle-controlled, multicenter, phase 3 clinical trial. Subjects Participants, and/or Controls: Four hundred and twelve (412) Demodex blepharitis patients were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution, 0.25% (study group) or vehicle without lotilaner (control group). Methods In this study, conducted at 21 U.S. clinical sites, Demodex blepharitis patients assigned to the study group (N=203) received lotilaner ophthalmic solution, 0.25% and those in the control group (N=209) received vehicle without lotilaner bilaterally, twice daily for six weeks. Patients were evaluated on Days 8, 15, 22, and 43. Collarettes and erythema were graded for each eyelid at screening and at all post-baseline visits. At screening, and on Days 15, 22, and 43, 4 or more eyelashes were epilated from each eye, and the number of Demodex mites present on the lashes was counted with a microscope. Mite density was calculated as the number of mites per lash. Main Outcome Measures 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. Conclusion 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.