The European Medicines Agency (EMA) has granted approval for Roche's Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for the treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This approval provides a new, more convenient administration option for a treatment already impacting millions across the European Union.
Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, emphasized the potential benefits of this approval, stating that it "offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss," and may "help reduce the treatment burden for patients and retina specialists."
Streamlining Treatment for Major Causes of Vision Loss
The Vabysmo PFS offers ophthalmologists a ready-to-use format, delivering the same 6.0 mg dose of faricimab as the currently available vials. Notably, the Vabysmo PFS includes a CE-labelled needle specifically designed for intravitreal injection. This approval marks a significant advancement as the first and only prefilled syringe in the EU to contain a bispecific antibody targeting retinal conditions that can lead to blindness.
These three retinal conditions collectively affect over nine million individuals in the European Union, often leading to significant physical, emotional, and economic burdens for patients and their families. The approval of Vabysmo PFS aims to address these challenges by simplifying the administration process and potentially improving treatment adherence.
Mechanism of Action and Global Availability
Vabysmo is a bispecific antibody that inhibits two key signaling pathways involved in vision-threatening retinal diseases: angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). By neutralizing Ang-2 and VEGF-A, Vabysmo stabilizes blood vessels, reduces the formation of leaky new blood vessels, and decreases inflammation. This dual mechanism of action addresses the underlying causes of vision loss in nAMD, DME, and RVO.
Vabysmo has gained approval in over 100 countries worldwide, including the United States, Japan, the United Kingdom, and the European Union, for the treatment of nAMD and DME. It is also approved in over 30 countries, including the US, EU, and Japan, for macular edema following RVO. The Vabysmo PFS was initially approved in the United States in July 2024.
