Sun Xinghuai, Yao Ke, Liu Qinghuai, Zhang Hong, Xing Xiaoli, Fang Aiwu, Duan Xuanchu, Yu Minbin, Chen Michelle Y, Yang Jingyuan, Goodkin Margot L
Eye & ENT Hospital of Fudan University, No. 83, Fenyang Road, Xuhui District, Shanghai, China.
Eye Center of the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Ophthalmol Ther. 2023 Feb;12(1):341-353. doi: 10.1007/s40123-022-00593-w. Epub 2022 Nov 12.
Fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort, Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limited. FCBT safety is evaluated herein, with particular focus on hyperemia and eyelash growth, at 24 weeks in Chinese patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
In this multicenter, open-label, noncomparative, phase 4 study conducted in China, patients diagnosed with OAG or OHT having insufficient response to β-blocker- or prostaglandin analogue/prostamide (PGA)-based IOP-lowering monotherapy in one or both eyes were switched from their current IOP-lowering treatment to FCBT (one drop per eye every evening) without prior washout. Assessment visits were scheduled at baseline and weeks 4, 12, and 24 (or study exit). The primary outcome measure was adverse event (AE) incidence through 24 weeks.
Of 725 patients enrolled, 632 (87.2%) completed the study; 93 (12.8%) patients discontinued, including 29 (4.0%) due to AEs. Of 1326 FCBT-treated eyes (total), 594 (44.8%) experienced ≥ 1 ocular treatment-related AE during the study. Conjunctival hyperemia (the most common AE overall) and eyelash growth were reported in 269 (20.3%) and 54 (4.1%) FCBT-treated eyes, respectively. The incidence of other known PGA-related AEs (including blepharal pigmentation and erythema of eyelid) was < 10% each. Most conjunctival hyperemia reports were mild in severity (214/259; 82.6%) and only 1/259 (0.4%) was severe. Similarly, most cases of eyelash growth were mild (46/52; 88.5%); none were severe. One (< 0.1%) FCBT-treated eye had a serious ocular AE (OAG) considered FCBT-related.
The frequency and severity of FCBT-related AEs, including conjunctival hyperemia and eyelash growth, are consistent with previously published findings. No new safety concerns were raised. This prospective study reaffirms that once-daily FCBT is a safe and well-tolerated therapy for OAG and OHT.
NCT02571712.
固定复方制剂比马前列素0.03%/噻吗洛尔0.5%滴眼液（FCBT，商品名Ganfort，艾尔建公司，艾伯维旗下公司）通过两种药物的互补作用机制有效降低眼压（IOP），但FCBT的长期（>12周）安全性评估仍然有限。本文对FCBT的安全性进行评估，特别关注中国开角型青光眼（OAG）或高眼压症（OHT）患者在24周时的结膜充血和睫毛生长情况。
在中国进行的这项多中心、开放标签、非对照4期研究中，诊断为OAG或OHT且单眼或双眼使用基于β受体阻滞剂或前列腺素类似物/前列腺酰胺（PGA）的降眼压单药治疗效果不佳的患者，在未进行前期洗脱的情况下，从当前的降眼压治疗转换为FCBT（每晚每眼一滴）。在基线、第4周、第12周和第24周（或研究结束时）安排评估访视。主要结局指标是24周内的不良事件（AE）发生率。
725例入组患者中，632例（87.2%）完成研究；93例（12.8%）患者停药，其中29例（4.0%）因AE停药。在总共1326只接受FCBT治疗的眼中，594只（44.8%）在研究期间发生≥1次与眼部治疗相关的AE。分别有269只（20.3%）和54只（4.1%）接受FCBT治疗的眼出现结膜充血（总体上最常见的AE）和睫毛生长。其他已知的与PGA相关的AE（包括眼睑色素沉着和眼睑红斑）发生率均<10%。大多数结膜充血报告为轻度（214/259；82.6%），只有1/259（0.4%）为重度。同样，大多数睫毛生长病例为轻度（46/52；88.5%）；无重度病例。1只（<0.1%）接受FCBT治疗的眼发生了1例被认为与FCBT相关的严重眼部AE（OAG）。
FCBT相关AE（包括结膜充血和睫毛生长）的频率和严重程度与先前发表的研究结果一致。未提出新的安全问题。这项前瞻性研究再次证实，每日一次的FCBT是一种治疗OAG和OHT安全且耐受性良好的疗法。
NCT02571712
