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Vabysmo
Published
Product name
Vabysmo
Active ingredient
Faricimab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Vabysmo (faricimab) was approved for the following therapeutic use:
Vabysmo is indicated for the treatment of:
- Neovascular (wet) age-related macular degeneration (nAMD)
- Diabetic macular oedema (DMO).
How this medicine works
Faricimab is a humanised bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of two distinct pathways by neutralisation of both angiopoietin-2 (Ang-2) and vascular endothelial growth factor A (VEGF-A).
Angiopoietin-2 (Ang-2) causes vascular instability by promoting endothelial destabilisation, pericyte loss, and pathological angiogenesis, thus potentiating vascular leakage and inflammation. It also sensitises blood vessels to the activity of VEGF-A resulting in further vascular destabilisation. Ang-2 and VEGF-A synergistically increase vascular permeability and stimulate neovascularisation.
By dual inhibition of Ang-2 and VEGF-A, faricimab reduces vascular permeability and inflammation, inhibits pathological angiogenesis and restores vascular stability.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Vabysmo was considered favourable for the therapeutic use approved.
Sponsor