FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss

The US FDA has approved Vabysmo PFS, a prefilled syringe containing the bispecific antibody faricimab, for treating neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Vabysmo PFS offers a convenient, ready-to-use alternative to existing Vabysmo vials. Vabysmo is the first and only bispecific antibody approved for ophthalmic use. It targets angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) to stabilize blood vessels and reduce vision loss. Vabysmo has demonstrated rapid and significant improvements in vision and retinal drying in clinical trials for AMD, DME, and RVO. Over 95 countries have approved Vabysmo for AMD and DME, and several, including the US and Japan, for RVO. Roche has a robust ophthalmology pipeline, including gene therapies and treatments for various eye diseases. Susvimo, Lucentis, and Vabysmo are among Roche's breakthrough ophthalmic therapies. Roche aims to save people's eyesight through scientific innovation and personalized healthcare.