Downie Laura E, Craig Jennifer P, Stapleton Fiona, Tan Jacqueline, Jones Lyndon W, Ng Alison, Hinds Mark, Bosworth Charles, Alster Yair
Department of Optometry and Vision Sciences, University of Melbourne, Parkville, Victoria, Australia.
Department of Ophthalmology, Aotearoa New Zealand National Eye Centre, The University of Auckland, Auckland, New Zealand.
Ocul Surf. 2025 Jan;35:15-24. doi: 10.1016/j.jtos.2024.11.008. Epub 2024 Nov 28.
To determine the efficacy and safety of AZR-MD-001 (0.5 % and 1.0 %) ophthalmic ointment, relative to vehicle, over 3-6 months of treatment, in participants with meibomian gland dysfunction (MGD).
This was a Phase 2, randomized, vehicle-controlled, multicenter extension clinical trial. Eligible participants were adults with MGD (meibomian gland secretion score (MGS) ≤12 out of 15 glands) who discontinued all other dry eye or MGD treatments. Participants were randomized 1:1:1 to apply AZR-MD-001 1.0 %, 0.5 %, or vehicle to the lower eyelids, twice weekly. Key exploratory endpoints included the least-squared mean difference between groups in the change from baseline in clinical signs (meibomian gland yielding score; MGYLS) and symptoms (Ocular Surface Disease Index; OSDI), at clinic visits at Month 4.5 and 6, and safety measures from 36 months.
Participants (66.5 % female) were randomized, at baseline, to AZR-MD-001 0.5 % (n = 82), 1.0 % (n = 83), or vehicle (n = 80). Statistically significant improvements, compared to vehicle, were observed at Month 6 in MGYLS for both AZR-MD-001 groups (0.5 % group: 1.9, 95 % CI 0.9 to 2.8, P = 0.002; 1.0 % group: 1.1, 95 % CI 0.2 to 2.1, P = 0.026), and in OSDI score for the 0.5 % group (-4.5, 95 % CI -8.0 to -0.9, P = 0.0135). The most common adverse events for AZR-MD-001 were application site pain, superficial punctate keratitis and eye pain; most were mild to moderate in severity, and decreased in incidence over time.
AZR-MD-001 (0.5 %) was efficacious in treating signs and symptoms of MGD over six months, with a lower observed incidence of new adverse events over time.
确定相对于赋形剂，AZR-MD-001（0.5%和1.0%）眼膏在治疗睑板腺功能障碍（MGD）参与者3至6个月期间的疗效和安全性。
这是一项2期、随机、赋形剂对照、多中心扩展临床试验。符合条件的参与者为患有MGD的成年人（睑板腺分泌评分（MGS）在15个腺体中≤12），他们已停止所有其他干眼或MGD治疗。参与者按1:1:1随机分组，每周两次在下眼睑涂抹1.0%的AZR-MD-001、0.5%的AZR-MD-001或赋形剂。关键探索性终点包括在第4.5个月和第6个月诊所就诊时，各治疗组之间在临床体征（睑板腺排出评分；MGYLS）和症状（眼表疾病指数；OSDI）从基线变化方面的最小二乘均值差异，以及36个月期间的安全性指标。
参与者（66.5%为女性）在基线时被随机分配至0.5%的AZR-MD-001组（n = 82）、1.0%的AZR-MD-001组（n = 83）或赋形剂组（n = 80）。与赋形剂组相比，在第6个月时，两个AZR-MD-001组的MGYLS均有统计学显著改善（0.5%组：1.9，95%CI 0.9至2.8，P = 0.002；1.0%组：1.1，95%CI 0.2至2.1，P = 0.026），0.5%组的OSDI评分也有改善（-4.5，95%CI -8.0至-0.9，P = 0.0135）。AZR-MD-001最常见的不良事件为用药部位疼痛、浅层点状角膜炎和眼痛；大多数严重程度为轻至中度，且随着时间推移发生率降低。
AZR-MD-001（0.5%）在治疗MGD的体征和症状方面6个月有效，且随着时间推移新不良事件的发生率较低。
