Vabysmo Prefilled Syringe Approved in the EU for Retinal Conditions

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

A Convenient Treatment Option for Vision Loss

The approval of Vabysmo PFS provides ophthalmologists with a simplified and convenient delivery method for administering treatment to patients with three of the most common causes of vision loss.

Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, emphasized the benefits of this new format:

“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. This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.”

About the Vabysmo Prefilled Syringe (PFS)

The Vabysmo PFS delivers the same medicine as the previously available 6.0 mg Vabysmo vials but in a ready-to-use format. It is the first and only CE-labelled needle for intravitreal injection, offering added convenience for ophthalmologists.

Key Features of Vabysmo PFS:

       • Ready-to-Use Format: Eliminates the need for additional preparation steps, reducing administration time.

       • Consistent Dosage: Provides the same therapeutic benefit as Vabysmo vials.

       • Proven Global Use: More than 5 million doses of Vabysmo have been distributed worldwide since its initial approval in the United States in 2022.

Vabysmo PFS was first approved for wet AMD, DME, and RVO by the FDA in July 2024. It now becomes the first and only prefilled syringe in the European Union containing a bispecific antibody to treat retinal conditions that can lead to blindness.

Global Approval and Reach

Vabysmo is now approved in more than 100 countries for the treatment of wet AMD and DME, including the US, Japan, the UK, and the EU. Additionally, the drug is approved in over 30 countries, including the US, EU, and Japan, for macular edema following RVO.

Key Markets for Vabysmo:

       • Wet AMD and DME: Approved in over 100 countries globally.

       • RVO: Approved in 30+ countries worldwide.

In the United States, Genentech, a wholly owned member of the Roche Group, is responsible for Vabysmo’s distribution.

Conclusion

The EMA’s approval of Vabysmo PFS marks a significant advancement in simplifying the administration of treatments for wet AMD, DME, and RVO. By offering a ready-to-use format, this approval not only reduces the treatment burden for ophthalmologists but also enhances convenience for patients managing these sight-threatening retinal conditions.

With its global reach and innovative delivery system, Vabysmo PFS is poised to improve outcomes for patients worldwide.