Demodex Collarettes, Mite Population Reduced After 6 Weeks of Lotilaner Treatment

Demodex collarettes and the mite population in patients with blepharitis can be significantly and safely reduced, according to a trial published in Ophthalmology. Patients with Demodex blepharitis who were treated with twice-daily lotilaner ophthalmic solution, 0.25% for 6 weeks demonstrated improved clinical outcomes compared with vehicle control patients, based on the findings of the phase 3 Saturn-2 trial (ClinicalTrials.gov Identifier: NCT04784091). 

Lotilaner, an anti-parasitic agent that causes spastic paralysis and death in Demodex mites, has been extensively evaluated in phase 2 and 2b/3 clinical trials. Saturn-2, a phase 3, randomized, double-masked, vehicle-controlled trial in the United States, sought to evaluate the efficacy and safety of lotilaner ophthalmic solution, 0.25% as a treatment for Demodex blepharitis. The primary outcome measure was the proportion of patients with collarette cure of the upper eyelid. A secondary endpoint included the proportion of patients with mite eradication and composite cure. 

The study enrolled 412 adult patients with the following clinical signs in the same eye: more than 10 upper-lid lashes with Demodex collarettes, at least mild erythema of the upper eyelid margin, and a mite density of at least 1.5 mites per lash on the upper and lower eyelids. The first dose was administered at day 1 in the clinic and subsequent twice-daily doses were administered at home by the patient for 6 weeks.

Researchers reviewed rates of collarette cure, collarette reduction, mite eradication, erythema cure, and composite cure in patients treated with the lotilaner ophthalmic solution. Patients were asked to not perform any mechanical lid scrubbing or use any other lid therapies during the study.

At baseline, patient characteristics were similar between the treatment arm (n=203) and control arm (n=209). A higher proportion of patients treated with lotilaner ophthalmic solution achieved Demodex collarette cure compared with patients in the control group (56.0% vs 12.5%; P <.0001). Patients in the treatment group also had higher rates of reduction of Demodex collarettes (89.1% vs 33.0%; P <.0001), as well as mite eradication, (51.8% vs 14.6%; P <.0001), erythema cure (31.1% vs 9.0%; P <.0001), and composite cure (19.2% vs 4.0%; P <.0001) compared with controls.

Lotilaner ophthalmic solution was well-tolerated and had a safety profile comparable to the vehicle. Treatment-related treatment-emergent adverse events (TEAEs) occurred in 19.2% of treated patients and 12.4% of controls. The most common TEAEs in the treatment group were instillation site pain (7.9%), dry eye (1.5%), chalazion (1.0%), conjunctival hyperemia (1.0%), eyelid pruritis (1.0%), photophobia (1.0%), instillation site irritation (1.0%), and presence of vital dye staining of the cornea (1.0%).

The resolution of erythema was slower than the elimination of mites and collarettes, according to the study authors. They hypothesize that, “it may take time for inflammation to resolve once mites and collarettes have been eradicated or resolved. Nearly one-third (31.1%) of TP-03 patients experienced complete resolution of lid erythema by the conclusion of the study.”

The collarette and erythema grading scales were not evaluated for inter- and intra-rater reliability. The study also did not evaluate long-term recurrence of Demodex infestation, although a long-term rollover study is underway. 

Disclosure: This research was supported by Tarsus Pharmaceuticals, Inc. Multiple study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.