Roche announced Friday that it received Food and Drug Administration approval for the first-ever bispecific antibody treatment for two common causes of vision loss, setting the stage for a battle with Regeneron, which markets a blockbuster drug in this space.
The approval comes just a week after two studies published in The Lancet showed that the drug, Vabysmo, proved safe and effective in improving or maintaining vision in patients with wet age-related macular degeneration and diabetic macular edema, conditions that together affect nearly 1.9 million people in the U.S. and 40 million worldwide.
The antibody drug latches onto vascular endothelial growth factor-A and angiopoietin-2 to block signals linked to inflammation and blood vessel leakage — both of which are major problems for patients with these eye conditions.
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