On 20 January 2025, Roche announced that Health Canada has approved its Vabysmo® (faricimab) 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of nAMD, diabetic macular oedema (DME) and macular oedema secondary to retinal vein occlusion (RVO). Vabysmo® PFS delivers the same dose as the currently available 6.0 mg vial formulation, and, according to Roche, will become available to Canadian ophthalmologists and their patients in the coming months.
Vabysmo® was first approved by Health Canada for nAMD and DME in June 2022, and for RVO in July 2024. This news follows EU approval for Vabysmo® PFS for the same indications in December 2024, and in the US in July 2024.