The approval is based on the positive results from the phase 3 BALATON and COMINO trials in which Vabysmo offered early and sustained improvement in vision in people with branch and central RVO
Roche building in Basel, Switzerland. (Credit: F. Hoffmann-La Roche Ltd)
Roche has received the US Food and Drug Administration (FDA) approval for Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO).
Vabysmo is a bispecific antibody that targets and inhibits two signalling pathways associated with several vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.
RVO is the third indication for Vabysmo. Previously, it was approved for neovascular or wet age-related macular degeneration (nAMD) and diabetic macular edema (DME).
The approval is based on the positive results from the global phase 3 BALATON and COMINO trials.
Both studies showed that monthly treatment with the bispecific antibody offered early and sustained improvement in vision in people with branch and central RVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks against aflibercept.
This was further supported by Vabysmo’s ability to dry retinal fluid quickly and thoroughly.
The drug was generally well accepted in BALATON and COMINO, and the safety profile was in line with previous trials.
The most frequent side effect was a 3% conjunctival haemorrhage. The safety outcomes were consistent across study arms.
Roche chief medical officer and global product development head Levi Garraway said: “Vabysmo is a new treatment option for RVO that can help people preserve and improve their vision, with the added benefit of retinal drying.
“The efficacy and safety profile of Vabysmo has been well established in global clinical trials and is reinforced by a growing breadth of real-world evidence, with hundreds of thousands of people treated.”
BALATON and COMINO were two randomised, multicentre, double-masked, late-stage studies. They had a goal to assess the efficacy and safety of Vabysmo against aflibercept.
Key secondary endpoints were defined as the change in central subfield thickness and drying of retinal fluid, from baseline over time up to week 24.
Currently, the drug is authorised in over 80 countries globally for people living with nAMD and DME.