Results of a 6-week, phase 3 clinical trial suggest that lotilaner ophthalmic solution, an antiparasitic agent, significantly reduces mite density and collarettes associated with Demodex blepharitis with similar safety and tolerance outcomes as vehicle control drops.
Study design
This study was a phase 3, prospective, randomized, double-masked, vehicle-controlled, multicenter clinical trial in which 412 patients with Demodex blepharitis received either 0.25% lotilaner ophthalmic solution (treatment) or vehicle (control) twice daily for 6 weeks. Collarettes and erythema were graded at baseline and at follow-up visits on days 8, 15, 22, and 43. The number of mites was determined via epilation of four eyelashes and microscopic exam at days 15, 22, and 43.
Outcomes
At the end of the treatment period, 56% of lotilaner-treated patients had collarette cure vs 12.5% of patients in the control group, and the majority of treated patients (89.1%) achieved collarette grade 0 or grade 1 (10 or fewer collarettes) compared to 33% of controls. Patients were highly compliant (98.7%), with 90.7% of patients reporting the treatment drops to be neutral or very comfortable.
Limitations
As a 6-week study, duration is a limitation; it is unclear what the long-term mite and collarette reduction outcomes would be. Demodex reinfestation from a patient's residence may occur. Additionally, the collarette and erythema grading scales that were used in this and previous phase 2 and phase 3 studies have not been evaluated for interrater and intrarater reliability.
Clinical significance
Demodex blepharitis is a prevalent condition with an estimated 25 million affected patients in the United States.1 The only currently available treatments, however, focus on providing symptomatic relief. Lotilaner, which has been successfully used to eradicate fleas and ticks in pets, would be the first medication to address the underlying mite infestation. This study supports the results of prior phase 3 studies, suggesting lotilaner is an effective and well-tolerated treatment to reduce mites and associated collarettes. While further studies will be required to see if improvements in mite and collarette load translate into symptomatic benefit for patients, lotilaner appears poised to become a helpful tool for addressing Demodex blepharitis.
Financial Disclosures: Dr. Daniel Choi discloses financial relationships with Glaukos Corporation (Lecture Fees/Speakers Bureau); Kala Pharmaceuticals (Consultant/Advisor).
Reference:
1 Teo A et al. Investigative Ophthalmology & Visual Science. 2021;62:1236