Topical Treatment for Demodex Blepharitis Shows Promise in Phase 3 Trial

Lotilaner ophthalmic solution, 0.25% may be a safe and effective topical treatment for Demodex blepharitis, according to findings presented at the American Academy of Optometry 2022 annual meeting, held in San Diego, CA from October 26 to 29.

The investigators, which included Paul Karpecki, OD, Patrick Vollmer, OD, and Scott Schecter, OD, detailed their findings from the Saturn-2 trial (ClinicalTrials.gov Identifier: NCT04784091) — a phase 3 trial including 412 individuals across 21 sites. Study participants had more than 10 upper lashes with collarettes, mild or worse lid margin erythema, and at least 1.5 mites per lash on their upper and lower lids combined for at least 1 eye at baseline. Researchers applied 1 drop of lotilaner or vehicle per eye twice daily for 43 days. The primary endpoint was complete collarette cure (0-2 collarettes) for the upper lid at 43 days. The team also evaluated eradication of Demodex mites, erythema cure and cure based on combined collarette score and erythema score for the upper lid.

Participants treated with lotilaner ophthalmic solution, 0.25% experienced a higher percentage of complete collarette cure (56% vs 13%), clinically meaningful collarette cure (89% vs 33%), mite eradication (52% vs 14%), and complete erythema cure (33% vs 9%) compared with individuals who received vehicle treatment (P <.001 for all). A total of 96% of patients experienced at least 1 grade of collarette improvement and 87% of patients had no more than 0.5 mites per lash by the end of the study period.

No serious adverse events were reported and 91% of patients rated lotilaner as being neutral to very comfortable. 

“There are yet no FDA-approved topical therapeutic options for treating Demodex blepharitis,” according to the poster presenters. “Saturn-2 study results further demonstrated (in addition to Saturn-1 results) that lotilaner ophthalmic solution, 0.25% may be a safe and efficacious treatment for treating Demodex blepharitis.”