European Commission approves Roche’s Vabysmo for treatment of
retinal vein occlusion (RVO)
- Approval is based on data
from two Phase III studies in branch and central retinal vein
occlusion (RVO) showing early and
sustained vision improvements non-inferior to aflibercept, and
robust retinal drying with Vabysmo
- Additional submitted data
shows that up to 60% of people receiving Vabysmo
were able to extend treatment intervals to three or four
months
- Vabysmo is already approved
in several countries, including the US and Japan, for RVO and in
nearly 100 countries for people with nAMD and DME
Basel, 30 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the European Commission (EC) has approved
Vabysmo® (faricimab) for the treatment of visual impairment due to
macular edema secondary to retinal vein occlusion (RVO, branch RVO
or central RVO). RVO is the third indication for Vabysmo in the
European Union, in addition to neovascular or ‘wet’ age-related
macular degeneration (nAMD) and diabetic macular edema
(DME).1 Together, the three retinal conditions affect
close to 80 million people worldwide and are among the leading
causes of vision loss.2-5
“Vabysmo is a new treatment option for people with retinal vein
occlusion in Europe that can help preserve and improve vision, with
the added benefit of retinal drying,” said Levi Garraway, M.D.,
Ph.D., Roche’s Chief Medical Officer and Head of Global Product
Development. “The efficacy and safety of Vabysmo has been well
established in global clinical trials and is reinforced by a
growing breadth of real-world evidence, with hundreds of thousands
of people treated worldwide.”
The approval is based on positive results from two global Phase
III BALATON and COMINO studies, evaluating Vabysmo in more than
1,200 people with macular edema due to branch and central retinal
vein occlusion (BRVO and CRVO).6,7
“People with retinal vein occlusion have limited treatment
options which require regular clinic visits,” said Prof. Frank
Holz, chairman and professor, Department of Ophthalmology,
University of Bonn, Germany. “This approval could have a
significant impact for people who have retinal vein occlusion and
their caregivers, who together have to navigate the devastating
impact of their disease on their ability to drive, read, socialise,
travel and pursue hobbies.”
Results demonstrated that monthly treatment with Vabysmo
provided early and sustained improvement in vision in people with
BRVO and CRVO, meeting the primary endpoint of non-inferior visual
acuity gains at 24 weeks compared to aflibercept. This was further
supported by data showing Vabysmo achieved rapid and robust drying
of retinal fluid.8 Retinal drying is an important
clinical measure as swelling from excess fluid in the back of the
eye has been associated with distorted and blurred
vision.9
Additional longer-term data up to 72-weeks showed that nearly
60% of people receiving Vabysmo in BALATON and nearly 48% of people
in COMINO were able to extend their treatment intervals to three or
four months apart.8 Current available treatments for RVO
are typically given every one to two months.10,11
In both studies, Vabysmo was well tolerated, and the safety
profile was consistent with previous studies.
Vabysmo is the first and only bispecific antibody approved for
the eye, uniquely engineered to target and inhibit two signalling
pathways, which are linked to a number of vision-threatening
retinal conditions, by neutralising angiopoietin-2 (Ang-2) and
vascular endothelial growth factor-A (VEGF-A) to restore vascular
stability.12-15
Vabysmo was first approved for RVO by the United States (US)
Food and Drug Administration in October 2023, and by the Japan
Ministry of Health, Labour and Welfare in March
2024.12,16 To date, Vabysmo is available in nearly 100
countries for people with nAMD and DME, with more than four million
doses distributed globally.1,12,13,16-18
About retinal vein occlusion (RVO)
RVO is the second most common cause of vision loss due to retinal
vascular diseases. It affects an estimated 28 million adults
globally, mainly those aged 60 or older, and can lead to severe and
sudden vision loss.5,19 The level of angiopoietin-2
(Ang-2) is elevated in RVO and it is thought that increased Ang-2
expression drives disease progression, alongside vascular
endothelial growth factors (VEGF).20,21 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.19,22,23 Currently,
macular edema due to RVO is typically treated with repeated
intravitreal injections of anti-vascular endothelial growth factor
therapies.22 There are two main types of RVO: branch
retinal vein occlusion, 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 retinal vein
occlusion, which is less common, affecting more than four million
people worldwide, and occurs when the eye’s central retinal vein
becomes blocked.5,23
About the BALATON and COMINO
studies6,7
BALATON (NCT04740905) and COMINO (NCT04740931) were two randomised,
multicentre, global Phase III studies evaluating the efficacy and
safety of Vabysmo®️ (faricimab) compared to aflibercept. For the
first 20 weeks, patients were randomised 1:1 to receive six monthly
injections of either Vabysmo (6.0 mg) or aflibercept (2.0 mg). From
weeks 24-72, all patients received Vabysmo (6.0 mg) up to every
four months using a treat-and-extend dosing regimen.
The BALATON study was conducted in 553 people with branch
retinal vein occlusion. The COMINO study was conducted in 729
people with central retinal or hemiretinal vein occlusion.
The primary endpoint of each study was the change in
best-corrected visual acuity from baseline at 24 weeks. Secondary
endpoints included change in central subfield thickness and drying
of retinal fluid from baseline over time up to week 24.
About the Vabysmo® (faricimab) clinical development
programme
Roche has a robust Phase III clinical development programme for
Vabysmo. The programme includes AVONELLE-X (NCT04777201), an
extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300),
evaluating the long-term safety and tolerability of Vabysmo in
neovascular or ‘wet’ age-related macular degeneration (nAMD), and
RHONE-X (NCT04432831), an extension study of YOSEMITE (NCT03622580)
and RHINE (NCT03622593) evaluating the long-term safety and
tolerability of Vabysmo in diabetic macular edema
(DME).24,25 Roche has also initiated several Phase IV
studies, including the ELEVATUM (NCT05224102) study of Vabysmo in
underrepresented patient populations with DME, the SALWEEN study of
Vabysmo in a subpopulation of nAMD highly prevalent in Asia, and
the POYANG (NCT06176352) study of Vabysmo in adult
treatment-naive patients with choroidal neovascularisation
secondary to pathologic myopia.26-28 Roche has also
initiated the VOYAGER (NCT05476926) study, a global real-world data
collection platform, and supports several other independent studies
to further understand retinal conditions with a high unmet
need.29
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the
eye.12-14 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.14,15 Vabysmo is approved in
nearly 100 countries, including the United States (US), Japan, the
United Kingdom and the European Union for people living with
neovascular or ‘wet’ age-related macular degeneration and diabetic
macular edema and in several countries, including the US and Japan,
for retinal vein occlusion. Review by other regulatory authorities
is ongoing.
1,12,13,16-18
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, 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 (US) Food and Drug Administration-approved
refillable eye implant for neovascular or ‘wet’ age-related macular
degeneration (nAMD) that continuously delivers a customised
formulation of ranibizumab over a period of months.30,31
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.12-15 Vabysmo is approved around the world for
people living with nAMD and diabetic macular edema, and in several
countries, including the US and Japan, for macular edema following
retinal vein occlusion.1,12,13,16-18 Lucentis®
(ranibizumab injection)* was the first treatment approved to
improve vision in people with certain retinal
conditions.11
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 endeavour 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 fifteenth 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.
*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] European Medicines Agency. Summary of product characteristics,
Vabysmo. 2022. [Internet; cited July 2024]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[2] Bright Focus Foundation. Age-related macular degeneration:
facts & figures. 2023. [Internet; cited July 2024]. Available
from:
https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
[3] 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. Surv Ophthalmol. 2022
Jul-Aug;67(4):1244-1251.
[4] The Lancet. Diabetes: a defining disease of the 21st century.
Lancet. 2023 Jun 24;401(10394):2087.
[5] Song P, et al. Global epidemiology of retinal vein occlusion
(RVO): a systematic review and meta-analysis of prevalence,
incidence, and risk factors. J Glob Health. 2019
Jun;9(1):010427.
[6] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with macular edema secondary to
branch RVO (BALATON) [Internet; cited July 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740905.
[7] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with macular edema secondary to
central retinal or hemi RVO (COMINO) [Internet; cited July 2024].
Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931.
[8] Ghanchi, et al. Efficacy, safety, and durability of faricimab
in macular edema due to RVO: 72-week results from the Phase III
BALATON and COMINO trials. Poster presented at: ARVO Annual
Meeting, May, 5-9 2024, Seattle WA, US. Poster #A0388.
[9] United States (US) National Institutes of Health - National Eye
Institute. Macular edema. 2023. [Internet; cited July 2024].
Available from:
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema.
[10] US Food and Drug Administration (FDA). Highlights of
prescribing information, aflibercept 2 mg. 2022. [Internet; cited
July 2024]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf.
[11] US FDA. Highlights of prescribing information, Lucentis. 2014.
[Internet; cited July 2024]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.
[12] US FDA. Highlights of prescribing information, Vabysmo. 2023
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf.
[13] Medicines and Healthcare products Regulatory Agency approves
faricimab through international work-sharing initiative. [Internet;
cited July 2024]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[14] Heier JS, et al. Efficacy, durability, and safety of
intravitreal faricimab up to every 16 weeks for neovascular macular
degeneration (nAMD) (TENAYA and LUCERNE): two randomised,
double-masked, Phase III, non-inferiority trials. The Lancet.
2022;399:729-40.
[15] 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.
[16] 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
July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[17] Chugai obtains regulatory approval for Vabysmo, the first
bispecific antibody in ophthalmology, for nAMD and DME. [Internet;
cited July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[18] Roche data on file.
[19] Moorfields Eye Hospital, United Kingdom National Health
Service Foundation Trust. RVO. [Internet; cited July 2024].
Available
from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion.
[20] 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.
[21] Regula JT, et al. Targeting key angiogenic pathways with a
bispecific CrossMab optimised for neovascular eye diseases. EMBO
Molecular Medicine. 2016;8:1265–88.
[22] Schmidt-Erfurth U, et al. Guidelines for the management of RVO
by the European Society of Retina Specialists (EURETINA).
Ophthalmologica. 2019;242:123-162.
[23] Campochiaro P. Molecular pathogenesis of retinal and choroidal
vascular diseases. Prog Retin Eye Res. 2015;49:67-81.
[24] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with nAMD (AVONELLE-X).
[Internet; cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04777201.
[25] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with DME (Rhone-X).
[Internet; cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04432831.
[26] Clinical Trials.gov. A study to investigate faricimab
treatment response in treatment-naïve, underrepresented patients
with DME (ELEVATUM). [Internet; cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT05224102.
[27] APVRS. Design and rationale of the SALWEEN trial: A Phase
IIIb/IV study of faricimab, a dual angiopoietin-2 and vascular
endothelial growth factor-a inhibitor, in patients with polypoidal
choroidal vasculopathy. [Internet; cited July 2024]. Available
from: https://2022.apvrs.org/abstract/?code=200351.
[28] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in patients with choroidal neovascularisation
secondary to pathologic myopia (POYANG). [Internet; cited July
2024]. Available from:
https://www.clinicaltrials.gov/study/NCT06176352.
[29] Clinical Trials.gov. A real-world study to gain clinical
insights into Roche ophthalmology products (VOYAGER). Internet;
cited July2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT05476926.
[30] US FDA. Highlights of prescribing information, Susvimo. 2021.
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[31] Holekamp N, et al. Archway randomised Phase III trial of the
Port Delivery System with ranibizumab for neovascular age-related
macular degeneration (nAMD). Ophthalmology. 2021.
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