Assessment Of Lotilaner Ophthalmic Solution, 0.25% In Demodex Blepharitis Patients With Meibomian Gland Disease

Demodex mites in the eyelashes are extremely common and can trigger meibomian gland disease (MGD) due to inflammation and obstruction of the gland orifices. Lotilaner ophthalmic solution, 0.25% is an FDA-approved ectoparasiticide for the treatment of Demodex blepharitis (DB) in the United States. This study is a pooled analysis of two studies evaluating the safety and efficacy of lotilaner ophthalmic solution, 0.25% (ERSA) compared with vehicle (RHEA) in DB patients with MGD.

Patients in ERSA and RHEA were randomly assigned in a 1:1 ratio to receive twice daily (BID) or three times daily (TID) of lotilaner ophthalmic solution, 0.25% (ERSA), or vehicle (RHEA), respectively, for 12 weeks.

This was a pooled analysis of ERSA (N=39) and RHEA (N=40), two separate prospective, randomized, double-masked studies evaluating 12-week treatment of BID or TID lotilaner ophthalmic solution 0.25% (ERSA) or vehicle (RHEA) in DB patients with MGD. Measures of meibomian gland secretion score (MGSS), number of glands yielding any liquid secretions (MGYLS), number of glands yielding clear liquid secretions (MGYCLS), patient-reported outcomes (Visual Analog Scale [VAS], 0-100), and safety were assessed. MGD severity (grades 1=subclinical, 2=mild, 3=moderate, and 4=severe) was graded based on quality of meibomian glands and patient-reported outcomes according to the grading scale from the International Workshop on MGD.

On day 85, means MGSS (33.2 vs 23.1, p<0.0001), MGYLS (12.7 vs 7.6, p<0.01), and MGYCLS (5.8 vs 1.3, p<0.001) in the lotilaner group were statistically significantly higher than vehicle. Lotilaner group reported statistically significantly better VAS scores in fluctuating vision, itching, burning, and redness than vehicle on day 85 (all p<0.05). The proportion of patients achieving mild or better MGD (grade ≤2) was statistically significantly greater in lotilaner group at day 85 vs vehicle (63% vs 24%, p=0.002). 74% of lotilaner-treated patients achieved ≥1 grade improvement in MGD severity, statistically significantly higher than 39% in vehicle (p=0.004). No treatment-related serious adverse events were reported.

Lotilaner ophthalmic solution, 0.25% demonstrated statistically significant improvements in meibomian gland function, patient-reported outcomes, and MGD severity in DB patients with MGD compared to vehicle. Lotilaner ophthalmic solution, 0.25% was well tolerated with a similar safety profile as the vehicle.