Roche’s Vabysmo for retinal vein occlusion marks the drug’s third indication for retinal conditions
Sarah Healey | | 2 min read | News
The US Food and Drug Administration (FDA) recently announced the approval of Vabysmo (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO) – a condition that affects an estimated 28 million adults globally (1). This marks the third indication for Vabysmo, in addition to wet age-related macular degeneration (nAMD) and diabetic macular edema (DME).
Representing the first bispecific antibody approved for the eye, Vabysmo works by targeting and inhibiting two signaling pathways (angiopoietin-2 and vascular endothelial growth factor-A), known to destabilize blood vessels, cause leaky blood vessels, and increase inflammation. By blocking the two pathways, Vabysmo is able to stabilize blood vessels and, in turn, preserve and improve vision.
The approval follows positive results from the global phase III BALATON and COMINO studies in people with branch and central retinal vein occlusion. These studies indicated early and sustained improvement in RVO patients’ vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. The studies were further supported by data highlighting that Vabysmo achieved rapid and robust drying of retinal fluid. “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,” said Roche’s Chief Medical Officer and Head of Global Product Development, Levi Garraway (2).
Vabysmo is now approved in over 80 countries, including the US, UK, and Japan, but extension studies are still underway. Roche’s phase III clinical development program for Vabysmo includes various studies aimed at assessing the long-term safety and tolerability of Vabysmo on nAMD and DME, with future studies likely delving into the long-term implications of RVO. Perhaps there’ll be more indications for this drug… watch this space.
- P Song et al., “Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors,” J Glob Health, 9, [Online ahead of print] (2019). PMID: 31131101.
- Roche, “[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO)” (2023). Available at: https://bit.ly/3QETIqa.