Yeu Elizabeth, Paauw James D, Vollmer Patrick, Berdy Gregg J, Whitson William E, Meyer John, Simmons Blake, Peterson Jared D, Periman Laura M, Boehmer Blair E, Bloomenstein Marc R, Whitley Walter O, Koetting Cecelia, Dhamdhere Kavita, Neervannan Sesha, Ciolino Joseph B
Virginia Eye Consultants, 241 Corporate Boulevard, Suite 210, Norfolk, VA, 23502, USA.
Piedmont Eye Center, Lynchburg, VA, USA.
Ophthalmol Ther. 2025 Mar;14(3):555-571. doi: 10.1007/s40123-024-01089-5. Epub 2025 Jan 28.
Lotilaner ophthalmic solution (0.25%) is the first United States Food and Drug Administration (US FDA)-approved drug for treating Demodex blepharitis. In pivotal trials, it was found to be well tolerated and demonstrated a significant reduction in collarettes and mite density after a 6-week treatment regimen. This study aimed to report the safety and efficacy profile of lotilaner ophthalmic solution (0.25%) from a pooled analysis of two pivotal trials in patients with Demodex blepharitis.
Pooled data were analyzed from two randomized, double-masked, vehicle-controlled clinical trials [phase 2b/3 Saturn-1 (NCT04475432) and phase 3 Saturn-2 (NCT04784091)] in which patients with Demodex blepharitis were randomly assigned in a 1:1 ratio to receive either lotilaner ophthalmic solution (0.25%) (study group) or the vehicle formulation without lotilaner (control group), twice daily for 6 weeks. The outcome measures were the proportion of patients with 0-2 collarettes (grade 0 collarettes), mite eradication, erythema cure, and the proportion of patients with ≤ 10 collarettes (grade 0 or 1 collarettes) at day 43.
Overall, 833 participants were randomized to receive either the study drug (N = 415) or vehicle (N = 418). On day 43, 49.8% of patients in the study group vs. 9.9% in the control group (p < 0.0001) had collarette grade 0 (0-2 collarettes). A reduction to ≤ 10 collarettes (grade 0 or 1 collarettes) was achieved in 85.1% of patients in study group vs. 28.0% in control group (p < 0.0001). The proportion of patients achieving mite eradication (60.2% vs. 16.1%, p < 0.0001) and erythema cure (24.9% vs. 7.9%, p < 0.0001) were also statistically significantly higher in the study group compared to the control group. The rates of adverse events were low in both studies, with no serious drug-related ocular adverse events reported. As many as 92% of patients rated the study drop as neutral to very comfortable.
Twice-daily treatment with lotilaner ophthalmic solution (0.25%) for 6 weeks demonstrated statistical significance for all outcome measures compared to the vehicle control, with low rates of adverse events and a high rate of drop comfort.
洛替拉奈眼用溶液（0.25%）是美国食品药品监督管理局（US FDA）批准的首个用于治疗睑缘蠕形螨睑缘炎的药物。在关键试验中，发现其耐受性良好，并且在6周治疗方案后，睑缘小结和螨虫密度显著降低。本研究旨在通过对两项睑缘蠕形螨睑缘炎患者关键试验的汇总分析，报告洛替拉奈眼用溶液（0.25%）的安全性和有效性概况。
对两项随机、双盲、赋形剂对照的临床试验[2b/3期Saturn-1（NCT04475432）和3期Saturn-2（NCT04784091）]的汇总数据进行分析，其中睑缘蠕形螨睑缘炎患者按1:1比例随机分配，接受洛替拉奈眼用溶液（0.25%）（研究组）或不含洛替拉奈的赋形剂制剂（对照组），每日两次，共6周。观察指标为在第43天时，睑缘小结为0-2个（0级睑缘小结）的患者比例、螨虫清除率、红斑治愈率，以及睑缘小结≤10个（0级或1级睑缘小结）的患者比例。
总体而言，833名参与者被随机分配接受研究药物（N = 415）或赋形剂（N = 418）。在第43天时，研究组49.8%的患者睑缘小结为0级（0-2个睑缘小结），而对照组为9.9%（p < 0.0001）。研究组85.1%的患者睑缘小结减少至≤10个（0级或1级睑缘小结），而对照组为28.0%（p < 0.0001）。研究组实现螨虫清除的患者比例（60.2%对16.1%，p < 0.0001）和红斑治愈的患者比例（24.9%对7.9%，p < 0.0001）也显著高于对照组。两项研究中不良事件发生率均较低，未报告严重的药物相关眼部不良事件。多达92%的患者对研究滴眼液的评价为中性至非常舒适。
与赋形剂对照相比，洛替拉奈眼用溶液（0.25%）每日两次治疗6周，在所有观察指标上均显示出统计学意义，不良事件发生率低，滴眼液舒适度高。
