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Lotilaner Boosts Meibomian Gland Function, With Mitchell Shultz, MD
Shultz discusses the impact of lotilaner ophthalmic solution 0.25% to treat active Demodex blepharitis in patients with meibomian gland dysfunction.
Lotilaner ophthalmic solution 0.25% (Xdemvy) achieved statistically significant improvements in meibum quality, meibomian gland function, and patient-reported symptoms at 12 weeks, compared with vehicle control, in a new meta-analysis of the ERSA and RHEA trials.
Presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, the studies assessed the safety and efficacy of lotilaner ophthalmic solution, 0.25%, for the treatment of patients with Demodex blepharitis and meibomian gland dysfunction (MGD).
“Approximately 57% of patients with Demodex blepharitis do have MGD,” Mitchell Shultz, MD, medical director of Shultz Chang Vision, told HCPLive. “Demodex mite infestation has a significant impact on meibomian gland function, and the reason is that the Demodex mites have bacteria that produce inflammatory mediators, which impact meibomian gland function in several different ways.”
The randomized, double-masked ERSA study (n = 39) and vehicle-controlled RHEA study (n = 40) assessed twice- and three-times-daily lotilaner ophthalmic solution dosing over 12 weeks. No difference was seen between dosing frequencies, but extending the treatment duration made a clear impact.
“At the 12-week timepoint, we could get 66% of patients to less than two collarettes per eyelid, which was a significant impact,” Shultz told HCPLive. “In the clinical trials, we saw about 85% of patients getting to less than 10 collarettes. With this treatment going for 12 weeks, we were able to get 100% of patients to fewer than 10 collarettes, which means they had improvement in functional treatment of Demodex and quality of life.”
Meibomian gland secretion also improved significantly with lotilaner ophthalmic solution 0.25%. At baseline, approximately 7 of 15 lower lid glands were functioning, which rose to 12.7 by week 12 in the active group. There was no notable improvement in the vehicle group.
“By the end of 12 weeks, we saw an improvement in the oil gland function, where we had 5.8 glands functioning with clear solution in the active arm of the study, whereas we had absolutely no impact utilizing the vehicle,” Shultz told HCPLive.
Significant improvements in patient-reported outcomes, including itching and redness, were also identified in the lotilaner ophthalmic solution, 0.25% group. Visual fluctuation dropped from 50% at baseline to approximately 13% after treatment, with itching falling from 45% to 14%, burning decreasing from 35% to 10%, and redness reduced from 45% to 12%.
Shultz emphasized that the utilization of lotilaner ophthalmic solution 0.25% solution to treat active Demodex blepharitis is impactful, not only in reducing Demodex blepharitis itself, but in increasing meibomian gland function, or protecting meibomian glands from getting damaged over time.
“If we manage this early, this has a significant impact on patients' quality of life, both by improving their quality of vision through reducing visual fluctuation, reducing their daily symptoms like itching as well as redness and burning,” Shultz told HCPLive.
Shultz reports relevant disclosures with Alchemy Vision, Alcon, Bausch + Lomb, Ocuphire, Tarsus Pharmaceuticals, and others.
