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视网膜输送的局部解决方案:贝瓦齐祖马布和拉尼比祖马布眼药滴在子的抗聚合配方 (AAF) 中
Steven A Giannos1, Edward R Kraft2, Jonathan D Luisi2
1Department of Ophthalmology and Visual Sciences, University of Texas Medical Branch, Galveston, TX, USA. stevena.giannos@viatris.com.
Pharmaceutical research
|June 5, 2024
概括
具有新型抗聚合配方 (AAF) 的局部眼滴成功将贝瓦西祖马布和拉尼比祖马布输送到子的视网膜. 这种局部输送方法显示出作为用于视网膜疾病的标准静脉内注射的辅助方法的潜力.
科学领域:
- 眼科医生 眼科 眼科
- 视网膜疾病 视网膜疾病
- 药物运输 药物运输 药物运输
背景情况:
- 潮湿的与年龄相关的黄斑变性 (AMD) 是导致失明的首要原因.
- 目前的标准治疗包括每月对抗VEGF抗体的静脉内注射,如贝瓦西祖马布和拉尼比祖马布.
- 抗体聚合可以阻碍眼睛的吸收和分布,可能限制治疗的疗效.
研究的目的:
- 评估局部输送稀释的抗VEGF抗体 (贝瓦西祖马布和拉尼比祖马布) 到子眼睛的后部.
- 评估一种新型抗聚合配方 (AAF) 在增强这些抗体的眼睛吸收和分布方面的有效性.
- 为了确定局部输送是否可以在视网膜组织中达到治疗度.
主要方法:
- 贝瓦西苏马布或拉尼比祖马布生物类似剂在AAF中稀释至5mg/ml.
- 子每天两次接受局部眼滴 (100微升为贝瓦齐祖马布,50微升为拉尼比祖马布生物类似剂).
- 采集了眼睛和血清样本,并使用AAF作为稀释剂分析了抗体度.
主要成果:
- 与PBS相比,在AAF中的贝瓦西祖马布在子的水性,玻璃性和视网膜中显示出10倍的透和积累.
- 每天两次服用AAF/氨酸眼滴,可以达到显著的视网膜度 (29.50 ng/g为贝瓦齐祖马布,18.0 ng/g为拉尼比祖马布生物类似剂).
- 检测到的血清度最小,没有观察到眼部刺激.
结论:
- 使用AAF稀释剂眼滴配方进行局部输送贝瓦西祖马布和拉尼祖马布是可行的.
- 这种方法可以有效地将单克隆抗体输送到视网膜.
- 局部抗VEGF眼滴可以作为用于管理视网膜疾病的内内注射的宝贵补充剂.
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