Roche’s Vabysmo approved by Swissmedic as the first bispecific antibody for the eye to treat two leading causes of vision loss

• Vabysmo (faricimab) targets and inhibits two disease pathways that drive neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular oedema (DME)
  
  
• Vabysmo is the first and only Swissmedic-approved bispecific antibody that improves and maintains vision with treatment intervals up to every 16-weeks in the first year

Basel, 7 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Swiss agency for therapeutic products (Swissmedic) has approved Vabysmo® (faricimab) for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME). Neovascular AMD and DME are two leading causes of vision loss worldwide.¹ Vabysmo is the first bispecific antibody for the eye. It targets and inhibits two disease pathways linked to a number of vision threatening retinal conditions by neutralising vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2).² By independently blocking each pathway, Vabysmo is designed to stabilize blood vessels, potentially improving vision for longer and with fewer injections than inhibition of one pathway alone, which represents the current standard of treatment.

Vabysmo is the first and only Swissmedic-approved injectable bi-specific antibody for the eye that improves and maintains vision with treatment intervals up to every 16-weeks in the first year for people with nAMD and DME.³

“Vabysmo represents an important step forward for the ophthalmology community”, said Jean-Marc Häusler, M.D., Country Medical Director, Roche Pharma Switzerland. “Both nAMD and DME can limit a person’s ability to read, drive, and recognise faces. Everyday activities like dressing, cleaning and shopping may become challenging as the disease progresses. With this first bispecific antibody approved for the eye we now have the opportunity to offer patients in Switzerland a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”

With an exponentially increasing prevalence of AMD by age⁵ and 3.5 million inhabitants in Switzerland aged >50 years⁶, about 360’000 are expected to be diagnosed with AMD. Of these, approximately 10-15%^7,8, i.e. 45’000 patients, have treatable nAMD.

About 4.4%⁹ of the total Swiss population suffers from diabetes. With a population of 7.1 million people aged >18 years⁶, this results in 313’000 diagnosed diabetics, of whom approximately 11.4%¹⁰, i.e. 35’700, develop DME.

About the Approval
The approval is based on positive results across four identical phase III studies in nAMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to 16- weeks achieved non-inferior vision gains versus aflibercept given every 8-weeks in the first year. Vabysmo was generally well tolerated in all four studies, with a favourable benefit-risk profile.^2,4 The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was conjunctival hemorrhage (7%).³ 

With Vabysmo, people with nAMD and DME are initially given four monthly treatments. Subsequently, their treatment may be extended or reduced based on anatomical and vision outcomes, with a range of 4 to 16 weeks between doses. Some people with nAMD and DME may be treated monthly if needed, although additional efficacy was not demonstrated in most people given Vabysmo every month.³

Vabysmo has already been approved in the United States and other countries around the world¹¹. The European Medicines Agency is also currently evaluating the Vabysmo Marketing Authorisation Application for the treatment of nAMD and DME.

About the TENAYA and LUCERNE Studies²
TENAYA n=671 (NCT03823287) and LUCERNE n=658 (NCT03823300) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,329 people living with neovascular or “wet” age related macular degeneration. The studies each have two treatment arms: Vabysmo 6.0 mg administered at intervals of every 8, 12- or 16-weeks following four initial monthly doses. Intervals were selected based on objective assessment of disease activity at weeks 20 and 24. The aflibercept 2.0 mg arm was administered at fixed 8-week intervals after three initial monthly doses.

The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score from baseline averaged over weeks 40, 44 and 48. Secondary endpoints included treatment durability, anatomical endpoints and safety outcomes. Both studies met their primary endpoint, demonstrating non-inferior vision gains of Vabysmo compared to aflibercept.

The key outcome of both studies is the strong durability effect of Vabysmo: After one year over 45% of patients achieved a 16-weeks dosing interval and nearly 80% of patients achieved a 12-weeks dosing interval or longer. Vabysmo was well tolerated and demonstrated a comparable safety profile to Aflibercept. No cases of vasculitis or occlusive retinitis were reported.

The robust vision gains and anatomical improvements underlines the potential of Vabysmo to optimize real-world treatment outcomes for patients with nAMD, whilst demonstrating a comparable safety profile to aflibercept.

About the YOSEMITE and RHINE Studies⁴
YOSEMITE n=940 (NCT03622580) and RHINE n=951 (NCT03622593) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,891 people with diabetic macular oedema. The studies each have three treatment arms: Vabysmo 6.0 mg administered up to every 16 weeks after four initial monthly doses using a treat-and extend approach; Vabysmo 6.0 mg administered at 8-week intervals after six initial monthly doses; and aflibercept administered at fixed 8-week intervals after five initial monthly doses.

The primary endpoint was the change in best-corrected visual acuity from baseline at one year, averaged over weeks 48, 52 and 56. Secondary endpoints included among others treatment durability, anatomical endpoints and safety outcomes.

Both studies met their primary endpoint, demonstrating non-inferior vision gains of Vabysmo compared to Aflibercept with intervals up to every 16 weeks. The key outcome of both studies is the strong durability effect of Vabysmo: At year one, over 50% of patients achieved a 16-weeks dosing interval; and more than 70% of patients were able to achieve a 12- or 16-weeks dosing interval. Central subfield thickness in either Vabysmo arm showed a numerically greater reduction compared to those treated with Aflibercept. In addition, there was a numerically greater proportion with an absence of intraretinal fluid in the Vabysmo arms.

Vabysmo was well tolerated and demonstrated a comparable safety profile to Aflibercept. No cases of vasculitis or occlusive retinitis were reported. The robust vision gains and anatomical improvements seen in the Vabysmo up to every 16 weeks-arm underlines the potential of Vabysmo to optimize real-world treatment outcomes for patients with DME, whilst demonstrating a comparable safety profile to Aflibercept. 

About neovascular age-related macular degeneration
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading.^12,13 Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.^14,15 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.¹⁵ Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.^12,16,17

About Diabetic Macular Oedema
Affecting around 21 million people globally, diabetic macular oedema (DME) is a vision threatening retinal condition associated with blindness and decreased quality of life when left untreated.^18,19 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.^13,20 The number of people with DME is expected to grow as the prevalence of diabetes increases.²¹ There remains a significant unmet need for more effective, longer-lasting therapies for people with DME.⁴

About Vabysmo™ (faricimab)^2-4
Vabysmo (faricimab) is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2). VEGF-A and Ang-2 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 VEG- A, Vabysmo is designed to stabilise blood vessels.

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 gene therapies and treatments for geographic atrophy and other vision-threatening diseases, including rare and inherited conditions.
 

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.

In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow

Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

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

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

References
[1] Heier JS, et al. The Angiopoietin/Tie pathway in retinal vascular diseases: a review. Retina-J Ret Vit Dis.  2021;41:1-19.
[2] Heier, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority  trials. The Lancet. 2022; https://doi.org/10.1016/S0140-6736(22)00010-1.
[3] Product information Vabysmo® (faricimab);  https://www.swissmedicinfo.ch/
[4] Wykoff 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 3 trials. The Lancet. 2022;  https://doi.org/10.1016/S0140-6736(22)00018-6.
[5]  Stadt Spital Triemli, “Die altersbezogene Makuladegeneration (AMD). Leitfaden für Patientinnen und Patienten.”; https://www.stadt-zuerich.ch/content/dam/stzh/triemli/Deutsch/Ueber%20das%20Departement/Kliniken_Institute/Augenklinik/Pdfs/Patienteninformationen/amd-leitfaden.pdf
[6] Bundesamt für Statistik, “Ständige Wohnbevölkerung nach Alter, Kanton, Bezirk und Gemeinde, 2010-2020”; https://www.bfs.admin.ch/bfs/de/home/statistiken/bevoelkerung/stand-entwicklung/bevoelkerung.assetdetail.18344310.html (accessed Mar. 19, 2022)
[7] J. Ambati and B. J. Fowler, “Mechanisms of Age-Related Macular Degeneration,” Neuron, vol. 75, no. 1, pp. 26–39, 2012, doi: 10.1016/j.neuron.2012.06.018.
[8] D. C. Neely, K. J. Bray, C. E. Huisingh, M. E. Clark, G. McGwin, and C. Owsley, “Prevalence of Undiagnosed Age-Related Macular Degeneration in Primary Eye Care,” Jama Ophthalmol, vol. 135, no. 6, p. 570, 2017, doi: 10.1001/jamaophthalmol.2017.0830.
[9] Bundesamt für Statistik, “Personen mit Diabetes nach Geschlecht, Alter, Bildungsniveau, Sprachgebiet,” n.d. https://www.bfs.admin.ch/bfs/de/home/statistiken/gesundheit/gesundheitszustand/krankheiten/diabetes.assetdetail.6466016.html (accessed Mar. 19, 2022).
[10]N. M. Holekamp, “Overview of Diabetic Macular Edema,” AJMC, vol. 22, pp. S284–S291, 2016.
[11] F. Hoffmann-La Roche, “Pharma Solutions”; https://www.roche.com/solutions/pharma/productid-0a6b3497-d8a2-4a5f-a2d4-b0ffa5769fea (accessed Jun. 09,2022).
[12] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures. [Internet; cited January 2022].  Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures
[13] All About Vision. Macula Lutea. [Internet; cited January 2022]. Available from:
https://www.allaboutvision.com/resources/macula.
[14] Pennington KL, et al. Epidemiology of age-related macular degeneration (AMD): associations with  cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.
[15] Little K, et al. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.
[16] 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;102:1691–5. 
[17] Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for  2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2:106–16. 
[18] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556- 64. 
[19] Park SJ, et al. Extent of exacerbation of chronic health conditions by visual impairment in terms of health related quality of life. JAMA Ophthalmol. 2015;133:1267-75. 
[20] National Eye Institute. Facts about diabetic eye disease [Internet; cited January 2022]. Available from:  https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy
[21] Liu E, et al. Diabetic macular oedema: clinical risk factors and emerging genetic influences. Clin Exp Optom.  2017;100:569-76.


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