Roche’s Vabysmo gets CHMP recommendation for third indication
retinal vein occlusion (RVO)
- Positive recommendation is
based on two Phase III studies. In addition to robust retinal
drying with Vabysmo, these data show early and sustained vision
improvements, which are non-inferior to aflibercept
- If approved, Vabysmo would
be the first and only bispecific antibody treatment available for
the nearly one million people with RVO in the European
Union
- Vabysmo is already approved
in the US and Japan for RVO and in more than 95 countries around
the world for people living with nAMD and DME
Basel, 28 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the European Medicines Agency’s Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion for the extension of the Vabysmo® (faricimab) marketing
authorisation to include the treatment of visual impairment due to
macular edema secondary to retinal vein occlusion (RVO). A final
decision regarding the approval is expected from the European
Commission in the near future.
“This CHMP recommendation represents an important step towards
bringing Vabysmo to even more patients living with vision loss in
Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “Recognising the
disruptive impact retinal vein occlusion can have on the everyday
lives and independence of these patients, we hope that Vabysmo will
offer a new treatment option that can effectively help preserve and
improve their vision.”
The CHMP decision is based on full 72-week data from the Phase
III BALATON and COMINO studies evaluating Vabysmo in more than
1,200 people with macular edema due to branch and central RVO (BRVO
and CRVO).1,2 In both studies, Vabysmo demonstrated
early and sustained vision improvements non-inferior to
aflibercept, and robust retinal drying. Vabysmo was well tolerated
and the safety profile was consistent with previous
studies.3 Current available treatments for RVO are
typically given every one to two months.
4,5
Vabysmo was first approved for RVO by the United States Food and
Drug Administration in October 2023 and by the Japan Ministry of
Health, Labour and Welfare in March 2024.6-8 It is
also approved in more than 95 countries around the world for people
living with neovascular or ‘wet’ age-related macular degeneration
(nAMD) and diabetic macular edema
(DME).6,8-11
Roche has the broadest retina pipeline in ophthalmology. Led by
science and informed by insights from people with eye conditions,
Roche is committed to saving people’s eyesight from the leading
causes of vision loss through pioneering treatments.
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.12,13 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.13,16,17
Currently, macular edema due to RVO is typically treated with
repeated intravitreal injections of anti-vascular endothelial
growth factor therapies.16 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.12,17
About the BALATON and COMINO
studies1,2
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).18,19 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.20-22 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.23
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye. 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.24 Vabysmo is approved in more than 95 countries
around the world, including the United States, 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
RVO.4,6-9 Review by other regulatory authorities is
ongoing.
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
across multiple vision-threatening conditions, including 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 was
approved by the U.S. Food and Drug Administration in
2021.25 Vabysmo is approved around the world 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 macular edema following retinal vein occlusion.
4,6-9 Lucentis® (ranibizumab
injection)* was the first treatment approved to improve vision in
people with certain retinal conditions.5
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] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with macular edema secondary to
branch retinal vein occlusion (RVO) (BALATON) [Internet; cited June
2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740905.
[2] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with macular edema secondary to
central retinal or hemiretinal vein occlusion (COMINO) [Internet;
cited June 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931.
[3] 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.
[4] 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.
[5] FDA. Highlights of prescribing information, Lucentis. 2014.
[Internet; cited June 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.
[6] FDA. Highlights of prescribing information, Vabysmo. 2022.
[Internet; cited June 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf.
[7] 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.
[8] 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.
[9] 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.
[10] Chugai obtains regulatory approval for Vabysmo, the first
bispecific antibody in ophthalmology, for neovascular age-related
macular degeneration (nAMD) and diabetic macular edema (DME)
[Internet; cited January 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[11] Roche data on file.
[12] Song P, et al. Global epidemiology of RVO: a systematic review
and meta-analysis of prevalence, incidence and risk factors. J Glob
Health. 2019;9:010427.
[13] Moorfields Eye Hospital, United Kingdom National Health
Service Foundation Trust. RVO [Internet; cited June 2024].
Available from:
https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion.
[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] Campochiaro P. Molecular pathogenesis of retinal and choroidal
vascular diseases. Prog Retin Eye Res. 2015;49:67-81.
[18] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with nAMD (AVONELLE-X)
[Internet; cited June 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04777201.
[19] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with DME (RHONE-X)
[Internet; cited June 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04432831.
[20] Clinical Trials.gov. A study to investigate faricimab
treatment response in treatment-naïve, underrepresented patients
with DME (ELEVATUM). [Internet; cited June 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT05224102.
[21] 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 June 2024]. Available
from: https://2022.apvrs.org/abstract/?code=200351.
[22] A study to evaluate the efficacy and safety of faricimab in
patients with choroidal neovascularisation secondary to pathologic
myopia (POYANG). [Internet; cited June 2024]. Available from:
https://classic.clinicaltrials.gov/ct2/show/NCT06176352.
[23] Clinical Trials.gov. A Real-World Study to Gain Clinical
Insights Into Roche Ophthalmology Products (VOYAGER). [Internet;
cited January 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT05476926.
[24] 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;399:729-740.
[25] FDA. Highlights of prescribing information, Susvimo. 2021.
[Internet; cited June 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
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