Health Canada authorizes VABYSMO® (faricimab injection) for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)

• Neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME) are two leading causes of vision loss in Canada¹
• VABYSMO^® (faricimab injection) is the first bispecific antibody that acts by neutralizing both VEGF-A and Ang-2 proteins, a dual mode of action (MoA) ^{2, 3, 4, 5}

MISSISSAUGA, ON, June 1, 2022 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that Health Canada authorized VABYSMO^® (faricimab injection) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME),⁶ two of the leading causes of vision loss among Canadians.¹

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.

"Faricimab, a new drug to treat wet AMD and DME, shows from the pivotal clinical trials an increase in treatment durability that may lessen the burden for patients and doctors while best maintaining our patient's vision," said Dr. David T. Wong, Ophthalmologist-in-Chief and Associate Professor, Unity Health at St. Michael's Hospital.

In wet AMD and DME, VABYSMO may improve vision outcomes with fewer injections into the eye⁷ – potentially helping to reduce the treatment burden for patients, caregivers, and their families.⁸

"The approval of VABYSMO is welcomed by Canadians living with wet AMD and DME," said Doug Earle, President and CEO, Fighting Blindness Canada. "It's critical to have treatment options and strategies that can reduce the burden of frequent injections for those living with a blinding eye disease. Frequent appointments can be challenging for both patients and caregivers, particularly for those in rural areas or with limited mobility – and access to treatment is critical to addressing vision loss."

Positive results from four Phase III studies support the potential of VABYSMO to offer an effective new treatment option for people living with DME and wet AMD, while maintaining a similar safety profile to the current standard of care.⁹

About the Health Canada Approval

In wet AMD, the Phase III TENAYA and LUCERNE studies show VABYSMO – when given at intervals of up to four months based on assessments of pre-specified visual and anatomic criteria at Weeks 20 and 24 as well as treating physician clinical assessment – consistently offers visual acuity gains non-inferior to the current standard of care, aflibercept. The primary endpoint of these studies is the average change in best-corrected visual acuity (BCVA) score from baseline. The average vision gains from baseline at one year in the VABYSMO arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms.¹⁰

In DME, the Phase III YOSEMITE and RHINE studies showed that VABYSMO met its primary endpoint with dosing intervals of up to every four months consistently shown to offer visual acuity gains that were non-inferior to aflibercept given every two months. According to these findings, the average vision gains from baseline at one year in YOSEMITE were +11.6 and +10.7 eye chart letters in the VABYSMO treat-and-extend and two-month arms, respectively (with +10.9 letters in the aflibercept arm); in RHINE, the average gains from baseline at one year were +10.8 and +11.8 letters in the VABYSMO treat-and-extend and two-month arms, respectively (with +10.3 letters in the aflibercept arm).¹¹

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,¹² and is a leading cause of vision loss among Canadians, affecting approximately 2.5 million Canadians.¹³ Wet, or neovascular AMD is an advanced form of the disease that can cause rapid and irreversible vision loss if left untreated¹⁴, and affects approximately 250,000 Canadians.¹⁵

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.¹⁶ If left untreated, this process results in a deterioration of sight over a period of months to years.¹⁷

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.¹⁸ 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. ¹⁹ The number of people with DME is expected to grow as the prevalence of diabetes increases.²⁰

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.²¹

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights, help Roche deliver truly personalized healthcare. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

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 us on Twitter @RocheCanada.

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¹ CNIB Foundation. The Cost of Vision Loss Report – Blindness in Canada. Available at: https://cnib.ca/en/sight-loss-info/blindness/blindness-canada?region=on. Accessed on May 3, 2022.

² VABYSMO Product Monograph, May 27, 2022.

³ BEOVU Product Monograph, February 17, 2022.

⁴ EYLEA Product Monograph, February 10, 2022.

⁵ LUCENTIS Product Monograph, December 21, 2021.

⁶ VABYSMO Product Monograph, May 27, 2022.

⁷ VABYSMO Product Monograph, May 27, 2022.

⁸ Review of Ophthalmology. "Easing the Anti-VEGF Treatment Burden". Available at: https://www.reviewofophthalmology.com/article/easing-the-antivegf-treatment-burden. Accessed on May 4, 2022.

⁹ VABYSMO Product Monograph, May 27, 2022.

¹⁰ VABYSMO Product Monograph, May 27, 2022.

¹¹ VABYSMO Product Monograph, May 27, 2022.

¹² Review of Neovascular Age-Related Macular Degeneration Treatment Options https://www.ajmc.com/view/review-of-neovascular-agerelated-macular-degeneration-treatment-options

¹³ 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 4, 2022.

¹⁴CNIB 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 4, 2022.

¹⁵ 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 4, 2022.

¹⁶ "Wet Age-Related Macular Degeneration". American Macular Degeneration Foundation, https://www.macular.org/wet-amd.

¹⁷ NHS. What is AMD? Available at: https://www.nhs.uk/conditions/age-related-macular-degeneration-amd/. Accessed on May 4, 2022.

¹⁸ 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 4, 2022.

¹⁹ 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.

²⁰ 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 4, 2022.

²¹ VABYSMO Product Monograph, May 27, 2022.

SOURCE Roche Canada

Jennifer Mota, Roche Canada, 437-219-7806, [email protected]; Deane Code, Weber Shandwick, 416-450-3091, [email protected]