Roche has announced that the United States Food and Drug Administration (FDA) has granted approval for the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for treating neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These conditions collectively impact nearly 80 million people globally. The Vabysmo PFS will be available to US retina specialists and their patients in the near future.
Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, expressed satisfaction with the FDA approval, highlighting the significance for individuals affected by these leading causes of vision impairment. He noted that while Vabysmo is already in use as a primary treatment, the new prefilled syringe format will simplify administration, potentially improving the treatment experience for both physicians and patients.
Vabysmo PFS delivers the same medication as the existing vials but in a convenient, ready-to-use format. The drug, a bispecific antibody targeting angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), has shown rapid and substantial improvements in vision and retinal drying across nAMD, DME, and RVO cases. These improvements are crucial as excessive fluid in the retina can lead to distorted and blurred vision.
Since its initial approval in the US in 2022, Vabysmo has been distributed globally, with more than four million doses administered. It is approved in over 95 countries for nAMD and DME, and in select countries including the US and Japan for RVO, with ongoing reviews by health authorities worldwide.
Vabysmo represents a significant advancement as the first bispecific antibody for ocular use, targeting pathways that destabilize blood vessels and contribute to vision loss. Its approval underscores its potential to stabilize blood vessels and improve outcomes for patients with these sight-threatening conditions globally.