Roche Vabysmo Prefilled Syringe Gains EU Approval, Transforming Retinal Disease Treatment

Roche Vabysmo Prefilled Syringe Gains EU Approval, Transforming Retinal Disease Treatment

(IN BRIEF) Roche’s Vabysmo® (faricimab) prefilled syringe has received European Medicines Agency approval for treating three major retinal conditions: neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema caused by retinal vein occlusion (RVO). Serving over nine million people in the EU, this ready-to-use syringe, the first of its kind to contain a bispecific antibody, simplifies treatment with a CE-marked needle for intravitreal injections. Already widely used globally since its U.S. approval in 2022, this innovation aims to reduce the treatment burden for patients and providers while maintaining robust results.

(PRESS RELEASE) BASEL, 13-Dec-2024 — /EuropaWire/ — Roche has announced that the European Medicines Agency (EMA) has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema resulting from retinal vein occlusion (RVO). Affecting over nine million people across the European Union, these conditions can significantly impact the lives of patients, their families, and caregivers.

This approval introduces the first and only prefilled syringe containing a bispecific antibody designed for retinal conditions. The Vabysmo PFS offers a convenient, ready-to-use alternative to the existing Vabysmo vial, simplifying treatment administration for ophthalmologists. Additionally, it comes co-packaged with the only CE-marked needle specifically developed for intravitreal injections, enhancing its practicality in clinical settings.

“The availability of the Vabysmo prefilled syringe in the EU provides a streamlined approach for delivering treatment to those affected by three of the leading causes of vision loss,” stated Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By simplifying the administration process, this option may help alleviate the treatment burden for both patients and retina specialists.”

Vabysmo has already demonstrated strong and rapid improvements in both vision and anatomical outcomes for individuals with nAMD, DME, and RVO. Since its initial approval in the United States in 2022, more than five million doses of Vabysmo have been distributed worldwide, highlighting its significant role in managing retinal conditions. The PFS version was approved by the US Food and Drug Administration (FDA) in July 2024 and now marks its entry into the European market as the first of its kind to utilize a bispecific antibody in a prefilled syringe format for retinal diseases.

This innovation underscores Roche’s commitment to advancing treatments that improve the quality of life for patients affected by debilitating vision conditions while supporting healthcare providers with efficient and effective solutions.

About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.7,8,12 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.12,13 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 30 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion. Review by other health authorities is ongoing.6-11

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.

Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration that continuously delivers a customised formulation of ranibizumab over a period of months.14,15 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.7,8,12,13 Vabysmo is approved around the world for people living with nAMD, diabetic macular edema and macular edema following retinal vein occlusion.6-11 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.16

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

*Lucentis® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.

All trademarks used or mentioned in this release are protected by law.

References
[1] National Institute for Health and Care Excellence. Macular degeneration – age-related: how common is it? [Internet; cited December 2024]. Available from: https://cks.nice.org.uk/topics/macular-degeneration-age-related/background-information/prevalence.
[2] Bright Focus Foundation. Age-related macular degeneration: facts & figures. [Internet; cited December 2024]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
[3] European Commission. Diabetes prevention. [Internet; cited December 2024]. Available from: https://knowledge4policy.ec.europa.eu/health-promotion-knowledge-gateway/diabetes-prevention.
[4] Im JHB, et al. Prevalence of diabetic macular edema (DME) based on optical coherence tomography in people with diabetes: A systematic review and meta-analysis. Survey of Ophthalmology. 2022 Jul-Aug;67(4):1244-1251.
[5] Li JQ, et al. Prevalence of retinal vein occlusion (RVO) in Europe: a systematic review and meta-analysis. Ophthalmologica. 2019;241(4):183-189.
[6] European Medicines Agency. Summary of product characteristics, Vabysmo. 2024. [Internet; cited December 2024]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[7] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024 [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf.
[8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited December 2024]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[9] 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 December 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[10] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, neovascular age-related macular degeneration (nAMD) and DME. [Internet; cited December 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[11] Roche data on file.
[12] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.
[13] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755.
[14] US FDA. Highlights of prescribing information, Susvimo. 2021. [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[15] Holekamp N, et al. Archway randomised phase III trial of the Port Delivery System with ranibizumab for nAMD. Ophthalmology. 2021.
[16] US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.

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SOURCE: Roche