On July 31, Roche (RHHBY.US) announced that the European Commission (EC) approved Vabysmo (faricimab) for the treatment of visual impairment due to retinal vein occlusion (RVO) associated with macular edema (ME). This is the third indication for Vabysmo in the EU, following neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). These three retinal diseases together affect nearly 80 million people, making them one of the main causes of blindness worldwide.
Vabysmo is a dual-acting antibody that simultaneously targets two key pathogenic pathways – Ang-2 and VEGF-A – which can both destabilize blood vessels and cause leakage, leading to inflammation and driving many retinal diseases that can cause vision loss. Targeting both pathways in a synergistic manner, Vabysmo has the potential to stabilize blood vessels and improve patients’ vision. Ang-2 expression is increased in patients with RVO, and an increase in Ang-2 expression is thought to be associated with the progression of this disease.
Research has shown that Vabysmo monthly dosing provides early and sustained visual improvement in both BRVO and CRVO patients, reaching the primary endpoint of not being inferior to abicipretin at 24 weeks. Additionally, data show rapid and significant reduction in retinal fluid.