Roche Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully complete negotiations for VABYSMO® (faricimab injection) for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)

MISSISSAUGA, ON, May 29, 2023 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for VABYSMO^® (faricimab injection), indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME),¹ two of the leading causes of vision loss among Canadians.¹

"Securing a letter of intent with the pCPA for VABYSMO is incredible news for patients and the vision loss community," said Larissa Moniz, Director, Research and Mission Programs, Fighting Blindness Canada. "We encourage the provinces to recognize the benefit that VABYSMO can bring to nAMD and DME patients, and prioritize public access for eligible Canadians."

VABYSMO is the first treatment for wet AMD and DME in Canada that acts by targeting both VEGF-A and Ang-2, two key drivers of vascular instability that have been associated with vision-threatening retinal conditions.^2,3,4,5 This unique dual MoA is made possible by Roche's antibody engineering expertise.

"This milestone is a critical step towards providing access to VABYSMO for Canadians living with vision loss from nAMD and DME," said Varun Chaudhary, Chief of Ophthalmology and Professor of Surgery, Hamilton Regional Eye Institute, McMaster University. "VABYSMO has demonstrated promising results in terms of efficacy, safety and durability of effect for both these diseases, and expedited public access for Canadians in need of this treatment is of paramount importance."

VABYSMO was reviewed and positively recommended by Canada's Health Technology Assessment bodies, including The Canadian Agency for Drugs and Technologies in Health (CADTH) in the fall of 2022, as well as Institut national d'excellence en santé et en services sociaux (INESSS) earlier in 2023, for the treatment of nAMD and DME.

As a next step, Roche Canada is committed to continuing to work with other provincial jurisdictions to make VABYSMO available as soon as possible through public drug plans.

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 and DME.²

About Wet Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is a condition that affects the macula, the part of the eye that provides sharp, central vision needed for activities like reading, driving, recognizing faces and seeing in colour,³ and is a leading cause of vision loss among Canadians, affecting approximately 2.5 million Canadians.⁴ Wet, or neovascular AMD is an advanced form of the disease that can cause rapid and irreversible vision loss if left untreated⁵, and affects approximately 250,000 Canadians.⁶

Wet AMD is caused by growth of abnormal blood vessels, also referred to as choroidal neovascularization (CNV), into the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina.⁷ If left untreated, this process results in a deterioration of sight over a period of months to years.⁸

About Diabetic Macular Edema
Affecting an estimated 15.7 per cent of Canadians with diabetes, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated.⁹ DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving.¹⁰ The number of people with DME is expected to grow as the prevalence of diabetes increases.¹¹

About Roche Canada
Patients and science are at the heart of everything we do. At Roche, our passion for science and our commitment to relentlessly pursuing the impossible for patients has made us one of the world's leading pharmaceutical, in vitro diagnostics, and healthcare technology companies. 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.

We're an innovator across major disease areas, including oncology, infectious diseases, diabetes, ophthalmology, and diseases of the central nervous system.

Roche Canada was founded in 1931 and employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec.

For more information, please visit www.RocheCanada.com, or follow Roche Canada on LinkedIn, or on Twitter @RocheCanada.

¹ VABYSMO Product Monograph, May 27, 2022.

² VABYSMO Product Monograph, May 27, 2022.

³ Review of Neovascular Age-Related Macular Degeneration Treatment Options https://www.ajmc.com/view/review-of-neovascular-agerelated-macular-degeneration-treatment-options

⁴ Fighting Blindness Canada. Eye Diseases - Age Related Macular Degeneration. Available at: https://www.fightingblindness.ca/eyehealth/eye-diseases/age-related-macular-degeneration. Accessed on May 1, 2023.

⁵ CNIB Foundation. Sight Loss Info – Age-related Macular Degeneration. Available at: https://cnib.ca/en/sight-loss-info/your-eyes/eye-diseases/age-related-macular-degeneration?region=on. Accessed on May 1, 2023..

⁶ Fighting Blindness Canada. Eye Diseases - Age Related Macular Degeneration. Available at: https://www.fightingblindness.ca/eyehealth/eye-diseases/age-related-macular-degeneration. May 1, 2023.

⁷ "Wet Age-Related Macular Degeneration". American Macular Degeneration Foundation, https://www.macular.org/wet-amd.

⁸ NHS. What is AMD? Available at: https://www.nhs.uk/conditions/age-related-macular-degeneration-amd/. Accessed on May 1, 2023.

⁹ Gonder, John R. et al. "Costs And Quality Of Life In Diabetic Macular Edema: Canadian Burden Of Diabetic Macular Edema Observational Study (C-REALITY)". Journal Of Ophthalmology, 2014. Available at: https://www.hindawi.com/journals/joph/2014/939315/#abstract. Accessed on May 1, 2023.

¹⁰ National Eye Institute. Learn About Eye Health - Macular Edema. Available at: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy. Accessed on May 4, 2022.

¹¹ Gonder, John R. et al. "Costs And Quality Of Life In Diabetic Macular Edema: Canadian Burden Of Diabetic Macular Edema Observational Study (C-REALITY)". Journal Of Ophthalmology, 2014. Available at: https://www.hindawi.com/journals/joph/2014/939315/#abstract. Accessed on May 1, 2023.

SOURCE Roche Canada

Media Contact: Jennifer Mota, Roche Canada, 437-219-7806, [email protected]