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Beovu
Published
Product name
Beovu
Active ingredient
Brolucizumab (rbe)
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Beovu (brolucizumab (rbe)) was approved for the following therapeutic use:
Beovu is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
How this medicine works
Brolucizumab is a humanised monoclonal single-chain Fv (scFv) antibody fragment. Increased levels of signalling through the vascular endothelial growth factor A (VEGF-A) pathway are associated with pathological ocular angiogenesis and retinal oedema in age-related macular degeneration. Brolucizumab binds with picomolar affinity to VEGF-A isoforms (for example, VEGF110, VEGF121, and VEGF165), thereby preventing binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A binding to its receptors, brolucizumab suppresses endothelial cell proliferation, thereby reducing pathological neovascularisation and decreasing vascular permeability.
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 Beovu was considered favourable for the therapeutic use approved.