Ophthalmic Surg Lasers Imaging Retina. 2024 Mar;55(3):156-162. doi: 10.3928/23258160-20240108-01. Epub 2024 Mar 1.
Indicated for colorectal cancer for decades, bevacizumab has been widely used off label to treat retinal diseases, and the benefits of its use, specifically in neovascular age-related macular degeneration, have been demonstrated in multiple clinical trials. The intravitreal delivery of bevacizumab requires it to be aseptically repackaged into individual syringes by compounding pharmacies for use in the eye. Although the repackaging process is permitted by the US Food and Drug Administration, the resultant product does not meet the specific standards of products approved for use as ophthalmic injectables nor is the parenteral innovator solution compliant with ophthalmic standards. Studies have also demonstrated variability in the quality and quantity of repackaged bevacizumab. This narrative review summarizes the evidence and discusses the role of off-label bevacizumab in the treatment and management of retinal diseases, its mechanism of action, current challenges and provides a critical appraisal of current evidence, clinical implications, and future directions. .
贝伐单抗已被广泛用于治疗视网膜疾病数十年，尽管其在治疗视网膜疾病方面的应用（特别是在新生血管性年龄相关性黄斑变性方面）已在多项临床试验中得到证实，但并未获得美国食品药品监督管理局的批准。贝伐单抗的玻璃体内给药需要由复方制剂药房进行无菌重新包装成单个注射器，以供眼部使用。尽管美国食品药品监督管理局允许重新包装，但由此产生的产品不符合批准用于眼科注射剂的产品的特定标准，也不符合眼科标准。研究还表明，重新包装的贝伐单抗的质量和数量存在差异。本文对现有证据进行了综述，讨论了贝伐单抗在治疗和管理视网膜疾病方面的作用、作用机制、当前的挑战，并对现有证据、临床意义和未来方向进行了批判性评估。
