Innovative biologic prefilled syringe approved in EU

The European Medicines Agency (EMA) has approved Roche’s Vabysmo ^® (faricimab) prefilled syringe (PFS) as the EU’s first and only bispecific antibody prefilled syringe for retinal conditions causing vision loss. This authorises a novel CE-labelled needle for intravitreal injection.

Vabysmo 6.0mg is indicated for treating neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO).

The biologic stabilise blood vessels in the eye by inhibiting two signalling pathways by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), Roche stated, based on prior research (Heier et al., Wykoff et al.).

Expanding market availability of Vabysmo

Vabysmo injection was approved by the European Commission (EC) in 2022 to treat these retinal conditions. The agency’s decision was based on four Phase III clinical trials in neovascular age-related macular degeneration and diabetic macular oedema.

At the time, Professor Ramin Tadayoni, Head of the ophthalmology department, Lariboisière, Saint-Louis and Rothschild Hospitals, Paris, France, and European Society of Retina Specialists (EURETINA) president elect explained that this authorisation provided “the first new mechanism of action in over a decade; one which could improve and protect their vision with fewer injections over time.”

Subsequently, Vabysmo PFS was granted first approval for the conditions by the US Food and Drug Administration (FDA) in July 2024, Roche shared.

Now, the EMA’s “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,” explained Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.”