Roche has announced that the European Medicines Agency (EMA) has given the green light to Vabysmo (faricimab) 6.0 mg prefilled syringe for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These three conditions collectively impact over nine million people in the European Union (EU) and pose significant physical, emotional, and economic challenges to those affected, as well as their families and caregivers.
“The EU’s approval of the Vabysmo prefilled syringe offers ophthalmologists a streamlined method of delivering treatment to individuals suffering from three predominant causes of vision impairment,” noted Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and head of global product development. “This easily-administered format may assist in reducing the overall treatment stress for patients and retinal specialists alike.”
The Vabysmo prefilled syringe offers the only CE-labelled needle for intravitreal injection, allowing ophthalmologists to use the same medicine as the existing 6.0 mg Vabysmo vials, but in a convenient, ready-to-use form. Since its initial approval in the US in 2022, over five million doses of Vabysmo have been distributed worldwide. The United States Food and Drug Administration first approved the Vabysmo prefilled syringe for nAMD, DME, and RVO in July 2024. This marks the first instance in the EU of a prefilled syringe equipped with a bispecific antibody aimed at treating retinal disorders that could lead to blindness.
Vabysmo distinguishes itself as the first bispecific antibody approved for ocular applications. It targets two critical signalling pathways linked to vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). These pathways, if left unaddressed, lead to destabilised blood vessels and the formation of leaky new vessels, which further exacerbates inflammation. Vabysmo functions by blocking these pathways, thereby aiming to stabilize the blood vessels. Vabysmo’s approval spans over 100 countries globally, including the US, Japan, the UK, and the entirety of the EU for those affected by nAMD and DME, and in over 30 countries for individuals dealing with macular edema following RVO. Evaluation by other health authorities is ongoing.
Roche’s commitment to preserving eyesight from major vision loss causes is illustrated through innovative therapies. Their exploration in identifying potential drug targets, facilitating personalized healthcare, delving into molecular engineering and biomarkers, and advancing continuous drug delivery methods exemplify their dedication to tailoring the right treatments to suitable patients.