Health Canada Authorizes Vabysmo® (faricimab injection) for the Treatment of Macular Edema Secondary to Retinal Vein Occlusion

•  This is the third indication for Vabysmo^®, in addition to neovascular or 'wet' age-related macular degeneration and diabetic macular edema ¹
•  Authorization is based on two phase III studies demonstrating early and sustained vision improvements that were non-inferior to aflibercept ¹
•  Vabysmo^® also demonstrated rapid and robust drying of retinal fluid ²

MISSISSAUGA, ON, July 29, 2024 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that Health Canada has authorized Vabysmo^® (faricimab injection) for the treatment of macular edema secondary to retinal vein occlusion (RVO).¹ RVO is the third indication for Vabysmo, in addition to neovascular or 'wet' age-related macular degeneration (AMD) and diabetic macular edema (DME).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.^3,4,5,6

"The expanded indication of retinal vein occlusion for Vabysmo provides an additional treatment option with durability to treat macular edema associated with this condition," said Dr. Wai-Ching Lam, vitreo-retinal surgeon. "The broadening of therapeutic choices presents a safe and effective option for people living with the condition."

The approval for RVO is based on two Phase III studies demonstrating early and sustained vision improvements in people with branch, central and hemiretinal RVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.¹ This was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluid.⁷

"We are delighted by the approval of Vabysmo for people living with retinal vein occlusion. Ensuring Canadians have access to advanced treatments that enhance their outcomes and quality of life is paramount," said Jennifer Jones, President and CEO of Fighting Blindness Canada. "Recognizing the significant impact of retinal vein occlusion on patients' daily lives, we are pleased that this provides another treatment option for affected Canadians."

Vabysmo is the first bispecific antibody that acts by neutralizing both VEGF-A and Ang-2 proteins, a dual mode of action (MoA).^1,8,9,10 In wet AMD, DME, 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

To date, Vabysmo is reimbursed on most private plans and publicly in several provinces for its indications in DME and AMD, including Ontario, Quebec, New Brunswick, Newfoundland, Nova Scotia, Prince Edward Island, Northwest Territories, and most recently on the Alberta Drug Benefit List in June 2024.

About the Health Canada Approval ¹
The safety and efficacy of Vabysmo were assessed in two randomized, multi-centre, double-masked, studies in patients with macular edema secondary to Branch Retinal Vein Occlusion (BRVO) (BALATON) or Central Retinal Vein Occlusion and Hemiretinal Vein Occlusion (CRVO/HRVO) (COMINO). A total of 1,282 patients (553 in BALATON and 729 in COMINO) were enrolled in the two studies, with 1,276 patients treated with at least one dose through week 24 (641 with Vabysmo). In both studies, the primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) at week 24, as measured by the ETDRS Letter Score. In both studies, Vabysmo Q4W treated patients had a non-inferior mean change from baseline in BCVA at week 24, compared to patients treated with aflibercept Q4W. In BALATON and COMINO, Vabysmo was generally well tolerated and the safety profile was consistent with previous trials.

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.^3,12. There are two main types of RVO: branch RVO, 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, which is less common, affecting more than four million people worldwide, and occurs when the eye's central retinal vein becomes blocked.^3,13 The level of angiopoietin-2 (Ang-2) is elevated in RVO and it is thought that increased Ang-2 expression drives disease progression.^14,15 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.^12,16,13 Currently, macular edema due to RVO is typically treated with repeated intravitreal injections of anti-vascular endothelial growth factor therapies.¹⁶

About Vabysmo® (faricimab)
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.¹ Vabysmo is also approved in more than 95 countries around the world for people living with neovascular or 'wet' age-related macular degeneration (AMD) and diabetic macular edema (DME).^{17,18,19,20,21}

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

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^{1 Vabysmo Product Monograph, July 25, 2024}

^{2 FDA approves Genentech's Vabysmo for the treatment of RVO [Internet; cited June 2024]. Available from: https://www.gene.com/media/press-releases/15009/2023-10-26/fda-approves-genentechs-Vabysmo-for-the-treatment-of-RVO. Accessed on July 16, 2024}

^{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 October 2023]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. Accessed on July 16, 2024}

^{7 FDA press release: https://www.gene.com/media/press-releases/15017/2024-01-31/new-long-term-data-for-genentechs-vabysm. Accessed on July 16, 2024}

^{8 BEOVU Product Monograph, Nov. 30, 2022.}

^{9 EYLEA Product Monograph, June 29, 2023}

^{10 LUCENTIS Product Monograph, December 21, 2021.}

^{11 Review of Ophthalmology. "Easing the Anti-VEGF Treatment Burden". Available at: https://www.reviewofophthalmology.com/article/easing-the-antivegf-treatment-burden. Accessed on July 16, 2024}

^{12 Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited October 2023]. Available from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion. Accessed on July 16, 2024}

^{13 Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog Retin Eye Res. 2015; 49:67-81.}

^{14 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.}

^{15 Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimised for neovascular eye diseases. EMBO Molecular Medicine. 2016; 8:1265–88.}

^{16 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.}

^{17 U.S. Food and Drug Administration (FDA). Highlights of prescribing information, aflibercept 2 mg. 2022. [Internet; cited June 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf. Accessed on July 16, 2024}

^{18 FDA. Highlights of prescribing information, Vabysmo. 2022. [Internet; cited June 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf. Accessed on July 16, 2024}

^{19 FDA approves Genentech's Vabysmo for the treatment of RVO [Internet; cited June 2024]. Available from: https://www.gene.com/media/press-releases/15009/2023-10-26/fda-approves-genentechs-Vabysmo-for-the-treatment-of-RVO. Accessed on July 16, 2024}

^{20 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 June 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html. Accessed on July 16, 2024}

^{21 European Medicines Agency. Summary of product characteristics, Vabysmo, 2022 [Internet; cited June 2024]. Available from: https://www.ema.europa.eu/en/documents/product-information/Vabysmo-epar-product-information_en.pdf. Accessed on July 16, 2024}

SOURCE Hoffmann-La Roche Limited (Roche Canada)

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