Mike: Hello, I'm Mike Clarke, podcast editor for the Cochrane Library. The Cochrane Eyes and Vision US Project prepares and maintains reviews across a wide range of conditions. These include neovascular age-related macular degeneration and their new review of its treatment by anti-vascular endothelial growth factor biosimilars was published in June 2024. Here's one of the authors, Sueko Ng from the Department of Ophthalmology in the University of Colorado Anschutz Medical Campus in the USA, to tell us more about the condition and this treatment.

Sueko: Neovascular age-related macular degeneration, called neovascular AMD, is a leading cause of vision loss globally. It's characterized by the growth of new blood vessels under the retina, a layer at the back of the eye, and can lead to severe visual impairment. The standard treatment of neovascular AMD involves injecting anti-vascular endothelial growth factor, or anti-VEGF agents directly into the eye, which, while effective, comes at a high cost and significant demand on healthcare resources. An alternative is to use a biosimilar, which is a biological product that has been developed to be nearly identical to already approved biological products, potentially offering a more cost-effective option.
In our Cochrane review, we assessed the potential benefits and harms of biosimilar agents compared with their original anti-VEGF counterparts, which we call reference products, and found that they are comparable.
We analyzed nine randomized controlled trials, enrolling more than 3800 participants with neovascular AMD, to compare these less costly anti-VEGF biosimilars, with the reference anti-VEGF products. All the studies had been supported by industry. Seven studies tested Ranibizumab biosimilar against reference Ranibizumab, Lucentis®, and the other two studies compared aflibercept biosimilar with reference aflibercept, Eyelea®. Five studies were conducted in multi-country settings across Europe, North America and Asia, with two other studies in India, and one each in Japan and the Republic of Korea.
As I mentioned, our overall finding is that the anti-VEGF biosimilars have similar benefits and harms to their reference products. For example, the change in vision after 8 to 12 weeks was almost the same, with less than one letter difference between those who used biosimilars and those who used reference products when people were tested using an eye chart. Additionally, when we looked at how many people experienced significant vision loss at 24 to 48 weeks, the results were very similar. Almost all participants, 96.6% in the biosimilar group and 97.0% in the reference product group, did not lose 15 or more letters in their best corrected visual acuity. Regarding safety, among the nearly 3300 participants in trials that reported this,1.4% in the biosimilar group and 1.2% in the reference group experienced serious eye problems, such as retinal hemorrhage or infection.
Despite these promising results, the evidence, which is of moderate to high certainty, still indicates a need for more research, particularly into long-term safety and quality of life impacts. There are also limited data on some biosimilars, especially when compared with aflibercept.
In conclusion, therefore, while anti-VEGF biosimilars appear to be a viable and more affordable option for treating neovascular AMD, further studies are needed to better understand their long-term benefits and harms.

Mike: If you would like to read this latest version of Sueko's review and watch for future updates as further research becomes available, it's available online. Just go to Cochrane Library dot com, and search 'anti-VEGF biosimilars' to find it.