Vabysmo Prefilled Syringe (PFS) Approved in the EU

The European Medicines Agency (EMA) has approved Roche's Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). 

“Approval of the Vabysmo prefilled syringe in the EU offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss,” Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said in a company news release. “This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.”

The Vabysmo PFS provides ophthalmologists with the first and only CE-labelled needle for intravitreal injection. Vabysmo PFS delivers the same medicine as the currently available 6.0 mg Vabysmo vials in an alternative, ready-to-use format. According to Roche, more than five million doses of Vabysmo have been distributed globally since its initial US approval in 2022. Vabysmo PFS was first approved for wet AMD, DME and RVO by the FDA in July 2024. Vabysmo PFS will be the European Union’s first and only prefilled syringe containing a bispecific antibody to treat retinal conditions that can cause blindness.  

Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with wet AMD and DME, and in more than 30 countries, including the US, EU and Japan, for people with macular edema following RVO. 

Genentech, in the United States, is a wholly owned member of the Roche Group.