VABYSMO® (faricimab injection) Now Publicly Funded For Macular Edema Secondary to Retinal Vein Occlusion (RVO) and Pre-Filled Syringe (PFS) in Quebec Français
MISSISSAUGA, ON, Aug. 15, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that VABYSMO ® (faricimab injection) is now publicly funded for macular edema secondary to retinal vein occlusion (RVO) on the Régie de l'assurance maladie du Québec (RAMQ) list of medications. 1 This latest update also includes funding for Vabysmo in a 6.0 mg single-use pre-filled syringe (PFS), providing an additional option and expanded access for patients in Quebec. Vabysmo received Health Canada authorization for treatment of macular edema secondary to retinal vein occlusion (RVO) in July 2024, and the approval of the PFS format in December 2024. 2
"This expansion in coverage for people with RVO in Quebec is welcome news in our mission to advance eye care and provide innovative solutions for people living with serious retinal conditions," said Carlene Todd, Vice President, Access at Roche Pharmaceuticals Canada. "We are deeply committed to ensuring equitable and timely access to our treatments, ensuring that provinces across the country prioritize access to innovative medicines that will ultimately improve the lives of people impacted by vision loss."
With this latest listing, Vabysmo is now covered in Quebec for all three of its indications and in both formats, including neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and the latest, macular edema secondary to retinal vein occlusion (RVO). These leading causes of vision loss affect around 70 million people worldwide and can have a serious impact on patients, their families, and caregivers. 3,4,5,6
"The recent reimbursement for RVO in Quebec is a significant step forward for people living with the condition," said Dr. Ananda (Andy) Kalevar, Associate Professor, Department of Ophthalmology at Sherbrooke University, Quebec. "It gives ophthalmologists a valuable treatment option and provides patients with access to a medication that may ultimately offer the best outcomes for their vision."
Roche Canada is committed to continuing to work with remaining provincial jurisdictions to make Vabysmo available through public and private drug plans for those living with RVO.
About retinal vein occlusion (RVO)
RVO is the second most common cause of vision loss due to retinal vascular conditions. It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss. 3,7 There are two main types of RVO: branch RVO (BRVO), which affects more than 23 million people globally and occurs when one of the four smaller 'branches' of the main central retinal vein becomes blocked; and central RVO (CRVO), which is less common, affecting more than four million people worldwide, and occurs when the eye's central retinal vein becomes blocked. 3,8
The levels of Vascular Endothelial Growth Factor A (VEGF-A) and angiopoietin-2 (Ang-2) are elevated in RVO and it is thought that their increased expression drives disease progression. 9,10 RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage and retinal swelling called macular edema. 7,11,8
The safety and efficacy of Vabysmo for the treatment of macular edema secondary to retinal vein occlusion (RVO) were assessed in two randomised, multi-centre, double-masked, studies in patients with macular edema secondary to BRVO (BALATON) or CRVO/hemiretinal vein occlusion (HRVO) (COMINO). Between Week 24 and Week 72, for patients who received faricimab Q4W/faricimab PTI, 49% of patients in BALATON and 34% of patients in COMINO completed at least one cycle of every 12 weeks (Q12W) and maintained ≥ Q12W dosing without an interval reduction below Q12W through Week 68; 32% of patients in BALATON and 24% of patients in COMINO completed 2 cycles of Q16W through Week 72. 2
About Vabysmo ® (faricimab injection)
Vabysmo is a humanized bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of both Ang-2 and vascular endothelial growth factor A (VEGF-A). By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability. By inhibiting Ang-2, faricimab is thought to increase vascular stability and desensitize blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with wet AMD, DME, and RVO. 2 In Canada, Vabysmo is authorized for the treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema secondary to retinal vein occlusion (RVO). 2 To date, Vabysmo is approved in more than 100 countries for DME and nAMD, and in over 30 countries for macular edema following retinal vein occlusion (RVO). 12,13,14,15,16,17
About Roche Canada
At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies.
With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and sustainable healthcare systems. We are committed to creating a world where we all have more time with the people we love.
And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.
Having the courage to reinvent ourselves and question the status quo is what patients and healthcare systems expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country from coast to coast to coast.
For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.
References
[1] RAMQ List of medications. Available at: https://www.ramq.gouv.qc.ca/en/media/25656. Accessed on August 14, 2025.
[2] Vabysmo Product Monograph, July 25, 2025
[3] Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427.
[4] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012; 35:556–64.
[5] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–95.
[6] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited August 2025]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. Accessed on August 6, 2025.
[7] Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited August 2025]. Available from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion. Accessed on August 6, 2025.
[8] Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog Retin Eye Res. 2015; 49:67-81.
[9] Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021; 35:1305-1316.
[10] Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimised for neovascular eye diseases. EMBO Molecular Medicine. 2016; 8:1265–88.
[11] Schmidt-Erfurth U, et al. Guidelines for the management of retinal vein occlusion by the European society of retina specialists (EURETINA). Ophthalmologica. 2019; 242:123-162.
[12] U.S. Food and Drug Administration (FDA). Highlights of prescribing information, aflibercept 2 mg. 2022. [Internet; cited August 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf. Accessed on August 6, 2025.
[13] FDA. Highlights of prescribing information, Vabysmo. 2022. [Internet; cited August 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf. Accessed on August 6, 2025.
[14] FDA approves Genentech's Vabysmo for the treatment of RVO [Internet; cited August 2025]. Available from: https://www.gene.com/media/press-releases/15009/2023-10-26/fda-approves-genentechs-Vabysmo-for-the-treatment-of-RVO. Accessed on August 6, 2025
[15] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited August 2025]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html. Accessed on August 6, 2025.
[16] European Medicines Agency. Summary of product characteristics, Vabysmo, 2022 [Internet; cited August 2025]. Available from: https://www.ema.europa.eu/en/documents/product-information/Vabysmo-epar-product-information_en.pdf. Accessed on August 6, 2025.
[17] Roche Data on File
SOURCE Hoffmann-La Roche Limited (Roche Canada)
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