학술논문

Evidence-Based Use of Bevacizumab in the Management of Neovascular Age-Related Macular Degeneration
Document Type
Academic Journal
Source
Ophthalmic Surgery, Lasers, and Imaging Retina. March, 2024, Vol. 55 Issue 3, p156, 7 p.
Subject
Company business management
Novartis AG -- Management
United States. Food and Drug Administration -- Management
Colorectal cancer -- Physiological aspects
Pegaptanib -- Physiological aspects
Drugstores -- Physiological aspects
Macular degeneration -- Physiological aspects
Drug approval -- Physiological aspects
Pharmacy -- Physiological aspects
Language
English
ISSN
2325-8160
Abstract
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. [Ophthalmic Surg Lasers Imaging Retina 2024;55:155–162.]
Age-related macular degeneration (AMD) is the leading cause of severe visual impairment and irreversible blindness in industrialized countries. (1) In 2019, it was estimated that in the United States (US), [...]