Lotilaner drops proven safe, effective in Demodex blepharitis

Treatment with lotilaner ophthalmic solution 0.25% twice daily for 6 weeks is well tolerated by patients with Demodex blepharitis and has no serious adverse effects compared to a vehicle control, according to a study. Moreover, use of this drop results in clinically meaningful outcomes.

“The results of this pivotal phase III study demonstrate that lotilaner ophthalmic solution 0.25% was superior to vehicle when dosed twice daily for 6 weeks for the treatment of Demodex blepharitis,” the researchers said.

A total of 412 patients with Demodex blepharitis treated at 21 clinical sites in the US were randomized to receive lotilaner ophthalmic solution 0.25% (study group; n=203) or vehicle without lotilaner (control group; n=209).

The researchers graded the collarettes and erythema for each eyelid at screening and at all visits after baseline. Four or more eyelashes were epilated from each eye at screening and on days 15, 22, and 43. A microscope was then used to count the number of Demodex mites on the lashes; mite density was calculated as the number of mites per lash.

More patients in the study group (p<0.0001) achieved collarette cure (56.0 percent vs 12.5 percent), clinically meaningful collarette reduction to 10 or fewer (89.1 percent vs 33.0 percent), mite eradication (51.8 percent vs 14.6 percent), erythema cure (31.1 percent vs 9.0 percent), and composite cure (19.2 percent vs 4.0 percent) than those in the control group. [Ophthalmology 2023;130:1015-1023]

Additionally, the study group demonstrated high compliance with the drop regimen (mean standard deviation, 98.7 percent). Of note, majority of the patients (90.7 percent) found the drops to be neutral to very comfortable.

Demodex mites

Previous studies reported the association between collarettes severity and a more severe infestation by Demodex mites. [Cornea 2021;40:995-1001; Invest Ophthalmol Vis Sci 2005;46:3089-3094; Cont Lens Anterior Eye 2020;43:115-122; Arch Soc Esp Oftalmol 2017;92:412-418]

In the present study, patients had an average collarette severity of grade 3 at baseline, which represented about 100 lashes with collarettes per lid. By week 6, the mean collarette score was 0.6, with almost all patients (96.4 percent) treated with lotilaner achieving an improvement in collarettes of at least 1 grade. Meaningful improvements began as early as day 8, according to the researchers.

Additionally, lotilaner was generally well tolerated and had a similar safety profile to that of the vehicle control among patients with Demodex blepharitis who received treatment with the study drug twice daily for up to 43 days.

Comfortable use

“Drop comfort on instillation can affect patient compliance and therefore efficacy of treatment,” the researchers said. [Clin Ophthalmol 2018;12:263]

Compliance with the drop regimen was high (mean, 98.6 percent) in the present study. This could be partially explained by the good tolerability of the regimen.

“[Lotilaner] is a first-in-class antiparasitic treatment for Demodex blepharitis, a lid margin disease that, despite being highly prevalent with a significant psychosocial impact on patients, currently has no approved treatments,” the researchers said. [Clin Ophthalmol 2022;16:2979-2987; Clin Ophthalmol 2022;16:1153-1164]