The United States Food and Drug Administration has approved a new injectable medication for patients with wet age-related macular degeneration, a leading cause of vision loss in older adults. The decision marks the first time a specific formulation of the drug has been cleared for use in this condition, offering an additional treatment option for millions of patients.
The newly approved drug, bevacizumab-vikg, is a biosimilar to the widely used cancer and eye disease treatment Avastin. It works by blocking a protein called vascular endothelial growth factor, which fuels the growth of abnormal blood vessels in the eye. These leaky vessels damage the macula, the central part of the retina responsible for sharp vision. In clinical trials, the treatment demonstrated comparable safety and effectiveness to the original biologic, with patients experiencing similar improvements in visual acuity.
Wet age-related macular degeneration affects approximately 1.5 million people in the United States. The condition progresses rapidly without treatment, often leading to severe vision loss within months. Current standard treatments include injections of anti-VEGF drugs such as ranibizumab and aflibercept, which require frequent doctor visits. Bevacizumab-vikg is administered as an injection into the eye, typically on a monthly or as-needed schedule determined by the physician.
Experts say the approval could help expand patient access to effective therapy. Biosimilars are often priced lower than their reference products, potentially reducing out-of-pocket costs for patients and easing the financial burden on healthcare systems. The FDA’s decision follows a rigorous review of manufacturing quality and clinical data.
Looking ahead, the manufacturer plans to launch the treatment in the coming months. Eye specialists anticipate that the availability of this new biosimilar will offer greater flexibility in managing wet AMD, particularly for patients who have struggled with the cost of existing therapies. Continued research into longer-acting formulations and combination treatments also holds promise for further improving outcomes and reducing the treatment burden for those living with this sight-threatening disease.