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news.Health Canada has granted authorisation to Roche Canada's Vabysmo (faricimab injection) to be used in a 6.0 mg single-use pre-filled syringe (PFS) for treating diabetic macular oedema, wet or neovascular, age-related macular degeneration (AMD), and macular oedema secondary to retinal vein occlusion (RVO).
The injection showed improvements in the vision and also drying of the retina. Credit: Marina Vitale on Unsplash.
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The company has announced that soon, the injection will be available to ophthalmologists and their patients, and ongoing efforts are being made to ensure accessibility via public and private drug plans.
Roche Canada Pharma president and CEO Brigitte Nolet said: “This milestone represents a significant step forward in our commitment to improving treatment options for individuals affected by serious retinal conditions. With this new PFS option, it should make it even simpler to administer, helping to enhance the treatment experience for both physicians and patients.”
Vabysmo showed ‘robust’ and ‘rapid’ improvements in the vision and also drying of the retina, especially in wet AMD, RVO, and diabetic macular oedema.
The injection offers the medication similar to the existing 6.0 mg vials but in a ready-to-use format.
Roche Canada noted that in conditions such as diabetic macular oedema, RVO, and wet AMD, the injection may enhance outcomes of the vision while requiring fewer eye injections, which helps in alleviating the treatment strain for individuals, caregivers, as well as their families.
As a humanised bispecific immunoglobulin G1 (IgG1) antibody, Vabysmo operates by blocking vascular endothelial growth factor A (VEGF-A). Through this, it suppresses endothelial cell proliferation, vascular permeability, as well as neovascularisation.
It also blocks Ang-2, and by doing so it augments vascular stability and eliminates the sensitivity of blood vessels to VEGF-A. Ang-2 levels are elevated in some subjects with these eye conditions.
Since its initial approval in the US in 2022, over six million Vabysmo doses have been distributed worldwide.
As of now, the injection is approved in over 100 nations for treating diabetic macular oedema and neovascular (wet) age-related macular degeneration.
