Zhang Zhen, Wu Ying, Lyu Ya-Li, Chang Meng-Qi, Xu Qiu-Jin, Liu Yi-Ming, Kang Wen-Ying, Wang Qing-Yu, Li Chuan-Ling
Department of Ophthalmology, Xuzhou Central Hospital, Xuzhou 221009, Jiangsu Province, China.
Department of Ophthalmology, Eye & ENT Hospital of Fudan University, Shanghai 200031, China.
Int J Ophthalmol. 2022 Sep 18;15(9):1549-1553. doi: 10.18240/ijo.2022.09.20. eCollection 2022.
To evaluate the efficacy and safety of HLX04-O, an investigational ophthalmic formulation of HLX04 (bevacizumab biosimilar) for intravitreal injection, as a treatment for wet age-related macular degeneration (wAMD) in a phase 1/2 clinical trial (NCT04993352).
Eligible patients with wAMD were enrolled to receive HLX04-O intravitreal injections at a dose of 1.25 mg/0.05 mL every four weeks. Efficacy and adverse events were evaluated every month during study visits.
A 76-year-old male with wAMD in his left eye participated in the trial and completed six cycles of HLX04-O intravitreal injections. Changes were observed in macular center point thickness (baseline last study visit, 437 255 µm) and best-corrected visual acuity letter score (baseline last study visit, 36 77) of the affected eye, which indicated an improvement in wAMD over treatment. No adverse events were reported by the data cutoff date.
HLX04-O at 1.25 mg/0.05 mL every four weeks is well tolerated in this patient, demonstrating promising safety and efficacy in wAMD treatment. Large-scale studies are required to confirm the outcomes.
在一项1/2期临床试验（NCT04993352）中，评估HLX04-O（一种用于玻璃体内注射的HLX04（贝伐单抗生物类似药）的眼科制剂）治疗湿性年龄相关性黄斑变性（wAMD）的疗效和安全性。
符合条件的wAMD患者入组，每四周接受一次剂量为1.25mg/0.05mL的HLX04-O玻璃体内注射。在研究访视期间每月评估疗效和不良事件。
一名76岁左眼患有wAMD的男性参与了试验，并完成了六个周期的HLX04-O玻璃体内注射。观察到患眼的黄斑中心点厚度（基线 末次研究访视，437 255µm）和最佳矫正视力字母评分（基线 末次研究访视，36 77）有变化，这表明wAMD在治疗后有所改善。截止数据日期时未报告不良事件。
该患者每四周接受1.25mg/0.05mL的HLX04-O耐受性良好，在wAMD治疗中显示出有前景的安全性和疗效。需要大规模研究来证实这些结果。
