At the 2025 ASCRS meeting, Mitch Shultz, MD, presented compelling new findings from a 12-week clinical trial investigating the impact of lotilaner 0.25% ophthalmic solution on meibomian gland function.
At the 2025 ASCRS meeting, Mitch Shultz, MD, an anterior segment surgeon based in Los Angeles, presented compelling new findings from a 12-week clinical trial investigating the impact of lotilaner 0.25% ophthalmic solution on patients with Demodex blepharitis. The study, sponsored by Tarsus, focused on the meibomian gland function—a key area of interest for optometrists managing ocular surface disease.
The clinical program consisted of 2 arms: the Ersa study, which administered active lotilaner (either BID or TID), and the Rhea study, a vehicle-controlled arm. Unlike prior studies (Saturn 1 and 2), which evaluated 6-week treatment courses, this research extended therapy to 12 weeks (85 days). Researchers aimed to determine whether prolonged treatment could provide additional benefits, particularly in meibomian gland function and overall ocular health.
The study found that lotilaner 0.25% ophthalmic solution was safe and effective over a 12-week treatment period, with no significant difference in outcomes or toxicity between BID and TID dosing—supporting BID as the preferred regimen. Importantly, patients experienced marked improvement in meibomian gland function. At baseline, participants had an average of 7 out of 15 glands functioning, with no clear gland secretions observed. By week 12, that number rose to approximately 13 functioning glands, with 5 to 6 glands producing clear secretions, indicating improved gland quality. These benefits are thought to result from lotilaner’s activity against both Demodex folliculorum and Demodex brevis, the latter of which resides deep within the meibomian glands and is difficult to detect. Symptomatic improvements were also notable: the percentage of patients reporting fluctuating vision dropped from 50% to 13%, while itching and redness decreased from about 50% to 14% and 12% to 14%, respectively. Additionally, extending the treatment duration led to greater success—clinical cure rates (defined as 0–2 collarettes) improved from 45% at 6 weeks to 66% at 12 weeks, and overall clinical success (1–10 collarettes) reached 100% by the end of the study.
For optometrists managing patients with Demodex blepharitis and associated meibomian gland dysfunction, this study reinforces the importance of targeted mite treatment and extended therapy duration. The data support lotilaner 0.25% as a safe, effective BID treatment that not only alleviates Demodex symptoms but also significantly improves gland function and visual quality.
This research underscores the evolving role of Demodex-targeted therapies in enhancing both ocular health and patient quality of life—valuable insight for front-line optometric care.
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