European Medicines Agency approves faricimab (Vabysmo) 6.0 mg single-dose prefilled syringe

Earlier this year, the European Commission approved faricimab for a third indication, macular oedema following retinal vein occlusion. Image credit: ©StudioLaMagica – stock.adobe.com

Roche announced that the European Medicines Agency (EMA) issued approval for faricimab (Vabysmo) in a 6.0 mg single-dose prefilled syringe (PFS). The PFS is approved for three indications: neovascular age-related macular degeneration (AMD), also known as wet AMD; diabetic macular oedema (DMO) and macular oedema following retinal vein occlusion (RVO).

Farcimab is already available in a 6.0 mg vial, and is now approved in this alternative format.¹ According to the press release from Roche, the faricimab PFS offers the first and only CE-labelled needle for intravitreal injection. The new faricimab PFS is the first and only prefilled syringe in the EU which contains a bispecific antibody to treat vision-threatening retinal disease.

Earlier this year, faricimab received European Commission approval for RVO, the third indication for the product.² That approval was confirmed at the end of July, following a positive CHMP opinion in late June.

Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said he hopes the approval represents hope for the nine million patients throughout the EU who are impacted by AMD, DMO and macular oedema following RVO.¹ “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,” he said. “This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.”

Faricimab is a bispecific antibody engineered to target and inhibit two signalling pathways linked to a number of vision-threatening retinal conditions. The agent neutralisies angiopoietin-2 and vascular endothelial growth factor-A. To date, faricimab is approved in 95 countries globally including the EU, UK, US and Japan.

References

1. Roche’s Vabysmo prefilled syringe (PFS) approved in the EU for three retinal conditions that can cause blindness. Roche. News release. Published 12 December, 2024. Accessed 13 December, 2024. https://www.roche.com/media/releases/med-cor-2024-12-13b

2. Hayes H. European Commission issues approval for faricimab (Vabysmo) for treatment of retinal vein occlusion. Ophthalmology Times Europe. Published 31 July, 2024. Accessed 13 December, 2024. https://europe.ophthalmologytimes.com/view/european-commission-issues-approval-for-faricimab-vabysmo-for-treatment-of-retinal-vein-occlusion