Roche’s Vabysmo maintained vision improvements with extended
treatment intervals up to four months for people with retinal vein
occlusion (RVO) in phase III studies
- Vabysmo showed robust and
sustained retinal drying up to 72 weeks and a safety profile
consistent with previous studies
- Regulatory applications for
Vabysmo in RVO are under review by health authorities around the
world; if approved, RVO would be the third indication in addition
to nAMD and DME
- Vabysmo is the first and
only treatment that targets and inhibits two signalling pathways
linked to a number of vision-threatening retinal
conditions
Basel, 10 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced positive topline long-term results from the global
phase III BALATON and COMINO studies, evaluating extended treatment
intervals with Vabysmo® (faricimab) in macular edema due to branch
and central retinal vein occlusion (BRVO and CRVO).1,2
From weeks 24 to 72, all people in both studies received Vabysmo
using a treat-and-extend dosing regimen, which allows tailoring of
their treatment interval according to the individual patient's
response to treatment. Data showed that people treated with Vabysmo
extended their treatment intervals up to every four months while
maintaining the vision gains achieved in the first 24 weeks of the
studies. Vabysmo continued to show robust and sustained drying of
retinal fluid from baseline up to week 72, as measured by reduction
in central subfield thickness. This is the first time that vision
and anatomical improvements have been maintained for more than a
year using a personalised treat-and-extend dosing regimen in global
phase III studies for both BRVO and CRVO. In both studies, Vabysmo
was generally well-tolerated and the safety profile was consistent
with previous studies.
“These are the first retinal vein occlusion (RVO) studies to
show vision maintenance and anatomical improvements up to 72 weeks
in both central and branch RVO,” said Levi Garraway, M.D., Ph.D.,
Roche’s Chief Medical Officer and Head of Global Product
Development. “These data further support Vabysmo’s potential as a
new treatment for RVO, allowing people to preserve their vision
while spending less time managing their condition.”
RVO impacts 28 million people globally and, if approved, would
be the third indication for Vabysmo in addition to neovascular or
‘wet’ age-related macular degeneration (nAMD) and diabetic macular
edema (DME).3-7 Together, the three conditions affect around 70
million people worldwide and are among the leading causes of vision
loss.3,8-11
Detailed results from weeks 24 to 72 of the phase III BALATON
and COMINO studies will be presented at an upcoming medical
meeting.
Data from the first 24 weeks of the phase III BALATON and COMINO
studies, presented at Angiogenesis, Exudation and Degeneration
2023, demonstrated early and sustained vision improvement with
Vabysmo, with both studies meeting their primary endpoints of
non-inferior vision gains compared to aflibercept. A secondary
endpoint showed that Vabysmo achieved rapid and robust drying of
retinal fluid from baseline to week 24, as measured by reduction in
central subfield thickness.12
Data up to 24 weeks have been submitted to global health
authorities, including the United States Food and Drug
Administration (U.S. FDA) and European Medicines Agency. A decision
from the U.S. FDA is expected in late 2023.
Vabysmo is 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.13,14 The level of Ang-2 is
elevated in RVO and it is thought that increased Ang-2 expression
drives disease progression.11,15
To date, Vabysmo is approved in more than 80 countries around
the world for people living with nAMD and DME, including the United
States, Japan, the United Kingdom and the European Union, with
public reimbursement in over 25 markets and more than 1.5 million
doses distributed globally.16
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.3,17 The level of angiopoietin-2 (Ang-2) is elevated in
RVO and it is thought that increased Ang-2 expression drives
disease progression.11,15 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 ischaemia,
bleeding, fluid leakage and retinal swelling called macular
edema.17-19 Currently, macular edema due to RVO is typically
treated with repeated intravitreal injections of anti-vascular
endothelial growth factor therapies.18 There are two main types of
RVO: branch retinal vein occlusion (BRVO), 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 (CRVO), which is less common,
affecting more than four million people worldwide, and occurs when
the eye’s central retinal vein becomes blocked.3,19
About the BALATON and COMINO
studies1,2BALATON (NCT04740905) and
COMINO (NCT04740931) are two randomised, multicentre,
double-masked, 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 to 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 (weeks
0-24) included change in central subfield thickness and drying of
retinal fluid, from baseline over time up to week 24. Secondary
endpoints (weeks 24-72) were treatment durability at 68 weeks and
continuation of weeks 0-24 endpoints.
About the Vabysmo® (faricimab) clinical development
programmeRoche has a robust phase III clinical development
programme for Vabysmo. The programme includes AVONELLE-X, an
extension study of TENAYA and LUCERNE, evaluating the long-term
safety and tolerability of Vabysmo in neovascular or ‘wet’
age-related macular degeneration (nAMD), and Rhone-X, an extension
study of YOSEMITE and RHINE, evaluating the long-term safety and
tolerability of Vabysmo in diabetic macular edema (DME).20.21 Roche
has also initiated several phase IV studies, including the ELEVATUM
study of Vabysmo in underrepresented patient populations with DME,
the SALWEEN study of Vabysmo in a subpopulation of nAMD highly
prevalent in Asia, as well as the VOYAGER study, a global
real-world data collection platform.22-24 Roche also supports
several other independent studies to further understand retinal
conditions with a high unmet need.16
About Vabysmo® (faricimab)Vabysmo is the first
bispecific antibody approved for the eye.4,6 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.13,14 Vabysmo is approved in more than 80 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. Review by other regulatory authorities is
ongoing.4-6,16
About Roche in ophthalmologyRoche 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.
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.25 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.4,6,13,14 Lucentis®
(ranibizumab injection)^ is the first treatment approved to improve
vision in people with certain retinal conditions.26
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 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.
^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
(BALATON) [Internet; cited October 2023]. 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
October 2023]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931.[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] U.S. Food and Drug Administration (FDA).
Highlights of prescribing information, Vabysmo. 2022. [Internet;
cited October 2023]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.[5]
Chugai obtains regulatory approval for Vabysmo, the first
bispecific antibody in ophthalmology, for neovascular age-related
macular degeneration and diabetic macular edema [Internet; cited
October 2023]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.[6]
MHRA approves faricimab through international work-sharing
initiative [Internet; cited October 2023]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.[7]
European Medicines Agency. Summary of Product Characteristics,
Vabysmo, 2022.[8] Yau JWY, et al. Global prevalence and major risk
factors of diabetic retinopathy. Diabetes Care. 2012;35:556–64.[9]
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.[10] 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.[11]
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.[12] Tadayoni R, et al. Faricimab in RVO: Results
from the BALATON and COMINO phase 3 studies. Presented at:
Angiogenesis, Exudation and Degeneration 2023, 10-11 February 2023;
Florida, United States.[13] Heier JS, 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; 399:729-740.[14] 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 3 trials. The Lancet.
2022; 399:741-755.[15] Regula JT, et al. Targeting key angiogenic
pathways with a bispecific CrossMab optimized for neovascular eye
diseases. EMBO Molecular Medicine. 2016;8:1265–88.[16] Roche data
on file.[17] 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.[18]
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.[19] Campochiaro P.
Molecular pathogenesis of retinal and choroidal vascular diseases.
Prog Retin Eye Res. 2015;49:67-81.[20] Clinical Trials.gov. A study
to evaluate the long-term safety and tolerability of Vabysmo in
participants with nAMD (AVONELLE-X) [Internet; cited October 2023].
Available
from: https://clinicaltrials.gov/ct2/show/NCT04777201.[21]
Clinical Trials.gov. A study to evaluate the long-term safety and
tolerability of Vabysmo in participants with DME (Rhone-X)
[Internet; cited October 2023]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04432831.[22]
Clinical Trials.gov. A study to investigate faricimab treatment
response in treatment-naïve, underrepresented patients with DME
(ELEVATUM). [Internet; cited October 2023]. Available
from: https://clinicaltrials.gov/ct2/show/NCT05224102.[23]
APVRS. Design and Rationale of the SALWEEN Trial: A Phase 3b/4
Study of Faricimab, a Dual Angiopoietin-2 and Vascular Endothelial
Growth Factor-A Inhibitor, in Patients With Polypoidal Choroidal
Vasculopathy. [Internet; cited October 2023]. Available
from: https://2022.apvrs.org/abstract/?code=200351.[24]
Clinical Trials.gov. A Real-World Study to Gain Clinical Insights
Into Roche Ophthalmology Products (VOYAGER). [Internet; cited
October 2023]. Available
from: https://clinicaltrials.gov/ct2/show/NCT05476926.[25]
U.S. FDA. Highlights of prescribing information, Susvimo. 2006
[Internet; cited October 2023]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.[26]
U.S. FDA. Highlights of prescribing information, Lucentis. 2006
[Internet; cited October 2023]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf
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