Safety & Efficacy Of Lotilaner Ophthalmic Solution, 0.25% In Treating Demodex Blepharitis: Pooled Analysis Of Two Pivotal Trials
Published 2024 - 42nd Congress of the ESCRS
Reference: FP07.09 | Type: Free paper | DOI: 10.82333/2zdf-bp97
Authors: Cathleen Mae Mccabe* 1 , Sumitra Khandelwal 2 , Arthur Chan 3 , Sara Siddiqi 3 , Elizabeth Yeu 4
1The Eye Associates,Sarasota, FL,United States, 2Alkek Eye Center, Baylor College of Medicine,Houston, TX,United States, 3Tarsus Pharmaceuticals, Inc,Irvine, CA,United States, 4Virginia Eye Consultants,Norfolk, VA ,United States
Purpose
The purpose of these two pivotal trials was to evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25% (Tarsus Pharmaceuticals) for the treatment of Demodex blepharitis.
Setting
This was a post-hoc pooled analysis of two randomized, double-masked, vehicle-controlled, pivotal clinical trials (Saturn-1 and Saturn-2). Saturn-1 recruited 421 patients across 15 US clinical sites and Saturn-2 recruited 412 patients across 21 US clinical sites.
Methods
The combined analysis of these two randomized, controlled, double-masked study included 833 subjects with >10 upper lid lashes with collarettes, mild or worse upper lid margin erythema, and ≥1.5 mites/lash on upper/lower lids combined in at least one eye. Subjects administered 1 drop of lotilaner or vehicle in each eye BID for 43 days. The primary endpoint was proportion of patients achieving collarette reduction to 0-2 collarettes for the upper lid of the analysis eye at day 43 (D43). Secondary endpoints were eradication of Demodex mites and erythema cure (Saturn-2 only). The proportion of patients achieving collarette reduction to ≤10 collarettes for the upper lid of the analysis eye was also collected.
Results
At Day 43, 49.8% of patients in the study group versus 9.9% in the control group (p<0.0001) had collarette reduction to 0-2 collarettes. Mite eradication was achieved in 60.2% in the study group versus 16.1% of the patients in the control group (p<0.0001). Erythema cure (24.9% versus 7.9%, p<0.0001) was also statistically significantly higher in the study group compared to the control group. Collarette reduction to ≤10 collarettes was achieved in 85.1% of patients in the study group versus 28.0% in the control group (p<0.0001). Instillation site pain/burning/stinging was the most frequently reported treatment emergent ocular adverse event. More than 90% of the patients reported the drop to be neutral to very comfortable.
Conclusions
Results of the combined analysis of two pivotal trials demonstrated the safety and efficacy of lotilaner ophthalmic solution, 0.25% for the treatment of Demodex blepharitis.