1. Long-Term Outcomes of 6-Week Treatment of Lotilaner Ophthalmic Solution, 0.25%, for Demodex Blepharitis: A Noninterventional Extension Study.
- Author
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Sadri E, Paauw JD, Ciolino JB, Nijm L, Simmons B, Meyer J, Gaddie IB, Berdy GJ, Holdbrook M, Baba SN, Jalalat P, and Yeu E
- Subjects
- Humans, Female, Male, Middle Aged, Animals, Aged, Treatment Outcome, Mites, Adult, Follow-Up Studies, Eyelashes parasitology, Aged, 80 and over, Blepharitis drug therapy, Blepharitis parasitology, Blepharitis diagnosis, Mite Infestations drug therapy, Mite Infestations parasitology, Mite Infestations diagnosis, Eye Infections, Parasitic drug therapy, Eye Infections, Parasitic parasitology, Eye Infections, Parasitic diagnosis, Ophthalmic Solutions
- Abstract
Purpose: The aim of this study was to evaluate the long-term outcomes of lotilaner ophthalmic solution, 0.25%, in the treatment of Demodex blepharitis., Methods: This observational, extension study included patients with Demodex blepharitis (N = 239) who completed the Saturn-1 study and presented for the day 180 visit. All participants were assessed at days 180 and 365 after the initiation of 6-week treatment with the study drug or its vehicle., Results: The proportion of patients with 0 to 2 collarettes (grade 0) was significantly higher in the study group (N = 128 patients) than in the control group (N = 111 patients) (39.8% vs. 2.7% at day 180 and 23.5% vs. 2.9% at day 365; P < 0.0001). Similarly, the proportion of patients with ≤10 collarettes (collarette grade 0-1) in the study group was significantly higher than in the control group (70.3% vs. 18.0% at day 180 and 62.6% vs. 21.9% at day 365; P < 0.0001). In the study group, erythema continued to improve even after completion of the 6-week lotilaner treatment. No serious ocular adverse events were observed in the study group, and there was 1 treatment-related ocular adverse event in the study group, which was considered mild., Conclusions: After 6-week treatment with lotilaner ophthalmic solution, 0.25%, for Demodex blepharitis, no long-term concerns were observed during 1 year of follow-up. A high proportion of patients with 0 to 2 collarettes (grade 0) or ≤10 collarettes (collarette grade of 0 or 1) was observed throughout 1 year of follow-up, indicating that the efficacy of lotilaner ophthalmic solution, 0.25%, against Demodex blepharitis may last well after completion of therapy., Competing Interests: E. Yeu has received consulting fees from, serves on the board of directors for, and is an equity stakeholder in Tarsus Pharmaceuticals. E. Sadri is a consultant for and an equity stakeholder in Tarsus Pharmaceuticals. I. B. Gaddie, J. B. Ciolino, and L. Nijm are consultants for Tarsus Pharmaceuticals. S. N. Baba and M. Holdbrook are or were employees of Tarsus Pharmaceuticals when this study was conducted. J. D. Paauw received research fees from Ora Clinical Research. The remaining authors have no conflicts of interest to disclose., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
- Published
- 2024
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