VABYSMO® (faricimab injection) receives positive CADTH recommendation for the treatment of Neovascular (wet) Age-related Macular Degeneration (nAMD) in adults
- The CADTH reimbursement recommendation is the latest step towards access to VABYSMO® (faricimab injection) for approximately the 2.5 million Canadians living with nAMD.1
- Provincial jurisdictions will make the final decision on public reimbursement.
MISSISSAUGA, ON, Sept. 1, 2022 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on August 30, 2022, the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) recommended VABYSMO® (faricimab injection) for public reimbursement. The recommendation is for the treatment of neovascular (wet) age-related macular degeneration (nAMD) in adults.2
"Clinical trials have demonstrated promising vision gains and durability signal with VABYSMO for patients suffering from nAMD," said Dr. Varun Chaudhary, Chief of Ophthalmology & Professor of Surgery at Hamilton Regional Eye Institute, McMaster University. "This positive recommendation from CADTH is a critical step forward for Canadians in our fight against this blinding disease."
VABYSMO provides a unique dual mode of action by targeting both VEG-F and Ang-2 proteins, two key drivers of vascular instability that have been associated with vision-threatening retinal conditions.3,4,5, This is the first treatment in Canada for nAMD that blocks both pathways.6,7,8,9 The CADTH recommendation acknowledges that VABYSMO can be given at an interval of up to every 16 weeks, which can help lessen treatment burden by extending the time between injections and appointments.2,10
"Regular treatment is key to preserving sight and maintaining the independence of people living with wet AMD," said Doug Earle, president and CEO, Fighting Blindness Canada. "It may be challenging to keep up with frequent appointments, especially for those living in remote or isolated communities, or requiring mobility assistance. These issues have further been exacerbated by COVID-19. With CADTH's recommendation, Fighting Blindness Canada encourages all provinces to give access to VABYSMO to offer the opportunity to reduce the burden of frequent injections and to provide meaningful treatment options for people living with wet AMD and their loved ones."
Roche Canada is pleased that the clinical evidence and benefit of VABYSMO have been recognized by CADTH for use in patients with nAMD and looks forward to partnering with the provinces and jurisdictions to help Canadians gain access to this new treatment for this indication. In addition, VABYSMO continues to undergo CADTH review for its other approved indication, for Diabetic Macular Edema (DME).
About Neovascular (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 (nAMD) is an advanced form of the disease that can cause rapid and irreversible vision loss if left untreated,5 and affects approximately 250,000 Canadians.4
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.11 If left untreated, this process results in a deterioration of sight over a period of months to years.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 and DME.6
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.
|1 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.|
|2 CDEC final recommendation, Faricimab (VABYSMO), August 30, 2022. Available at: https://www.cadth.ca/sites/default/files/DRR/2022/SR0719REC-Vabysmo.pdf. Last accessed August 31, 2022.|
|3 Review of Neovascular Age-Related Macular Degeneration Treatment Options – American Journal of Managed Care. Available at: https://www.ajmc.com/view/review-of-neovascular-agerelated-macular-degeneration-treatment-options. Accessed on May 18, 2022.|
|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 4, 2022.|
|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 4, 2022.|
|6 VABYSMO Product Monograph, May 27, 2022.|
|7 EYLEA Product Monograph, February 10, 2022.|
|8 LUCENTIS Product Monograph, December 21, 2021.|
|9 BEOVU Product Monograph, Feb 17, 2022.|
|10 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.|
|11 "Wet Age-Related Macular Degeneration". American Macular Degeneration Foundation, Available at https://www.macular.org/wet-amd. Accessed on May 4, 2022|
|12 National Health Service. What is AMD? Available at: https://www.nhs.uk/conditions/age-related-macular-degeneration-amd/. Accessed on May 4, 2022.|
SOURCE Roche Canada