Health Canada Authorizes Vabysmo® (faricimab injection) Pre-Filled Syringe (PFS) for Three Leading Causes of Vision Loss

• Vabysmo PFS is the first and only syringe prefilled with a Health-Canada approved bispecific antibody to treat retinal conditions that can cause blindness¹
• Designed to simplify administration, Vabysmo PFS provides retina specialists with a ready-to-use option
• Vabysmo PFS will be available for people living with wet AMD, DME and RVO

MISSISSAUGA, ON, Jan. 20, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that Health Canada has authorized Vabysmo^® (faricimab injection) for use in a 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO).¹ These leading causes of vision loss affect around 70 million people worldwide and can have a serious impact on patients, their families, and caregivers.^2,3,4,5

Supply for Vabysmo PFS will become available to Canadian ophthalmologists and their patients in the coming months. Roche Canada is committed to continuing to work with the provincial and territorial jurisdictions to make Vabysmo PFS available as soon as possible through public and private drug plans for the patients who need it.

Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME and RVO.^1,6,7,8 Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.⁹ This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid.¹⁰

"This milestone represents a significant step forward in our commitment to improving treatment options for individuals affected by serious retinal conditions," said Brigitte Nolet, President and CEO, Roche Canada Pharma. "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 PFS delivers the same medicine as the currently available 6.0 mg Vabysmo vials in an alternative, ready-to-use format.¹

"The new Vabysmo PFS is a game changer for simplifying the delivery of dual action anti-VEGF," says Dr. David T. Wong, Ophthalmologist-in-Chief and Associate Professor, Unity Health at St. Michael's Hospital. "It reduces the risk of infection and increases our efficiency to help maximize our clinic capacity, which helps us to better serve patients."

In wet AMD, DME, and RVO, Vabysmo may improve vision outcomes with fewer injections into the eye ¹ – potentially helping to reduce the treatment burden for patients, caregivers, and their families.¹¹ More than six million doses of Vabysmo have been distributed globally since its initial US approval in 2022.¹²

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.¹ To date, Vabysmo is approved in more than 100 countries for DME and neovascular or 'wet' age-related macular degeneration, and in over 30 countries for macular edema following retinal vein occlusion (RVO).^13-18

About Roche in Ophthalmology
Roche is focused on saving people's eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.

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 the 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, or on X / Twitter @RocheCanada.

References

	1.  Vabysmo Product Monograph, December 13, 2024.
	2. 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.
	3. Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012; 35:556–64.
	4. 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.
	5. Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited January 2025]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. Accessed January 2025
	6. BEOVU Product Monograph, November 30, 2022.
	7. EYLEA Product Monograph, June 29, 2023.
	8. LUCENTIS Product Monograph, September 28, 2022
	9. United States National Institutes of Health - National Eye Institute. Macular edema. 2023. [Internet; cited January  2025]. Available from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema.
	10. FDA press release: https://www.gene.com/media/press-releases/15017/2024-01-31/new-long-term-data-for-genentechs-vabysm. Accessed January 2025.
	11. Review of Ophthalmology. "Easing the Anti-VEGF Treatment Burden". Available at: https://www.reviewofophthalmology.com/article/easing-the-antivegf-treatment-burden.  Accessed January 2025.
	12. Roche data on file.
	13. European Medicines Agency. Summary of product characteristics, Vabysmo. 2022. [Internet; cited January 2025]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
	14. US FDA. Highlights of prescribing information, Vabysmo. 2023 [Internet; cited January 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf.
	15. Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited January 2025]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
	16. 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 January 2025]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
	17. Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited January 2025]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
	18. Roche data on file.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Media contact: Jennifer Mota, Strategic Corporate Communications, Hoffmann-La Roche Limited, 437-219-7806, [email protected]