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Roche (RHHBY.US) bispecific antibody Vabysmo is approved by the EU

2024-07-31

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Zhitong Finance APP learned that on July 31, Roche (RHHBY.US) announced that the European Commission (EC) has approved the bispecific antibody Vabysmo (faricimab) for the treatment of visual impairment caused by macular edema due to retinal vein occlusion (RVO). This is the third indication approved by Vabysmo in the EU. Previous indications include neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). These three retinal diseases together affect nearly 80 million people and are one of the main causes of vision loss worldwide.

It is understood that Vabysmo is a bispecific antibody that can simultaneously target and block two key pathogenic pathways - angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Both pathways can destroy the stability of blood vessels, cause blood vessels to leak, and increase inflammation, thereby driving many retinal diseases that can cause vision loss. Targeting these two pathways at the same time can play a certain complementary role, so Vabysmo is expected to stabilize blood vessels and improve patients' vision. Ang-2 expression increases in patients with retinal vein occlusion, and increased Ang-2 expression is believed to be associated with the progression of the disease.

The results of the study showed that monthly treatment with Vabysmo provided early and sustained visual improvement in patients with BRVO and CRVO, achieving the primary endpoint of visual improvement that was non-inferior to aflibercept at week 24. At the same time, the data showed that Vabysmo achieved rapid and significant regression of retinal fluid.