New long-term data for Roche’s Vabysmo show sustained retinal
drying and vision improvements in retinal vein occlusion (RVO)
- Vabysmo sustained robust
drying of retinal fluid, often associated with distorted or blurry
vision
- Up to 60% of people
receiving Vabysmo were able to extend treatment intervals to three
or four months apart
- Detailed results from two
global Phase III RVO studies will be presented at Angiogenesis,
Exudation, and Degeneration 2024
- Vabysmo is approved in the
US for RVO, and in more than 90 countries around the world for
people living with nAMD and DME
Basel, 1 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today new 72-week data from two global Phase III studies,
BALATON and COMINO, evaluating Vabysmo® (faricimab) in
macular edema due to branch and central retinal vein occlusion
(BRVO and CRVO).1,2 Whereas available RVO treatments are
typically given every one to two months, the data showed nearly 60%
of people receiving Vabysmo in BALATON and up to 48% of people in
COMINO were able to extend their treatment intervals to three or
four months apart.1,2,3,4 In addition, patients in the
studies maintained vision gains and robust retinal drying achieved
in the first 24 weeks of the studies for more than one year.
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.5 In both studies, Vabysmo
was well tolerated and the safety profile was consistent with
previous studies.
“This is the first time that vision and anatomical improvements
have been maintained for more than a year in global Phase III
studies for both branch and central retinal vein occlusion,” said
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head
of Global Product Development. “These long-term results build on
the strong clinical and real-world data reinforcing Vabysmo as an
effective treatment option for people affected by retinal
conditions that can cause vision loss.”
Results will be presented virtually on 3 February 2024 at
Angiogenesis, Exudation, and Degeneration 2024, organised by Bascom
Palmer Eye Institute in Florida, United States (US).
“The sustained vision improvements and retinal drying seen up to
72 weeks reaffirm Vabysmo as an effective treatment for retinal
vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of
ophthalmology at the Cité University in Paris, France, and
president of EURETINA, who is presenting the data at Angiogenesis.
“More treatment options are needed to better serve people living
with this condition, and these data show Vabysmo can potentially
improve outcomes while reducing the number of clinic visits
needed.”
Both studies evaluated the average change in best-corrected
visual acuity (BCVA) score (the best distance vision a person can
achieve – including with correction such as glasses – when reading
letters on an eye chart) from baseline. The studies also tracked
the amount of swelling in the back of the eye due to retinal fluid,
as measured by central subfield thickness (CST). Reductions in CST
indicate improvement. Overall, results showed the vision
improvements and reductions in retinal fluid achieved in the first
24 weeks of the studies were maintained up to 72 weeks.
Results for BRVO (BALATON)1:
- Vision gains: At 72 weeks, people receiving
Vabysmo as a first-line treatment gained 18.1 letters on the eye
chart, while people switched from aflibercept to Vabysmo gained
18.8 letters. During the first 24 weeks, vision gains were +16.8
eye chart letters in people receiving Vabysmo and +17.5 letters in
people receiving aflibercept.
- Retinal drying: At 72 weeks, people receiving
Vabysmo as a first-line treatment saw a 310.9 µm reduction in
retinal swelling, as measured by CST, while those switched from
aflibercept to Vabysmo saw a reduction in CST of 307 µm. During the
first 24 weeks of the study, CST reductions were 314.5 µm in people
receiving Vabysmo and 307.6 µm in people receiving
aflibercept.
Results for CRVO (COMINO)2:
- Vision gains: People receiving Vabysmo as a
first-line treatment gained 16.9 eye chart letters at 72 weeks,
while people switched from aflibercept to Vabysmo gained 17.1 eye
chart letters. During the first 24 weeks of the study, vision gains
were +16.9 eye chart letters in people receiving Vabysmo and +17.3
letters in people receiving aflibercept.
- Retinal drying: People receiving Vabysmo as a
first-line treatment saw a 465.9 µm reduction in retinal swelling,
as measured by CST, while those switched from aflibercept to
Vabysmo saw a reduction in CST of 460.6 µm at 72 weeks. During the
first 24 weeks of the study, reductions in CST were 462.3 µm in
people receiving Vabysmo and 447.8 µm in people receiving
aflibercept.
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.6-9
To date, Vabysmo is approved in more than 90 countries around
the world for people living with neovascular or ‘wet’ age-related
macular degeneration (nAMD) and diabetic macular edema (DME), with
public reimbursement in over 25 markets and more than 2.5 million
doses distributed globally.10
In October 2023, the U.S. Food and Drug Administration approved
Vabysmo for the treatment of macular edema following
RVO.6 Data up to 72 weeks from the BALATON and COMINO
studies have been submitted to health authorities around the world,
including the European Medicines Agency, for the treatment of
macular edema following RVO.
About the BALATON and COMINO
studies1,2
BALATON (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, people were randomised 1:1 to
receive monthly injections for six months of either Vabysmo (6.0
mg) or aflibercept (2.0 mg). From weeks 24 to 72, all individuals
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 change in best-corrected visual
acuity (BCVA) from baseline at 24 weeks. Secondary endpoints for
weeks 0-24 of the studies included change in central subfield
thickness (CST) and drying of retinal fluid, from baseline over
time up to week 24. Secondary endpoints for weeks 24-72 of the
studies assessed change in BCVA from baseline, change in CST from
baseline and the proportion of individuals on treat-and-extend
intervals.
About retinal vein occlusion (RVO)
RVO is the second most common cause of vision loss due to retinal
vascular conditions. It affects an estimated 28 million adults
globally, mainly those aged 60 or older, and can lead to severe and
sudden vision loss.11,12 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).13,14 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 bleeding, fluid leakage and retinal swelling
called macular edema.12,15,16 Currently, macular edema
due to RVO is typically treated with repeated intravitreal
injections of anti-VEGF therapies.15 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, affecting more than
four million people worldwide, and occurs when the eye’s central
retinal vein becomes blocked.11,16
About the Vabysmo®
(faricimab) clinical development programme
Roche 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).17,18 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.19-21 Roche also
supports several other independent studies to further understand
retinal conditions with a high unmet need.10
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the
eye.6,7 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.8,9 Vabysmo is approved in more
than 90 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 the United States for people living
with macular edema following retinal vein occlusion. Review by
other health authorities is
ongoing.6,7,10,22,23
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.
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.24
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.6-9 Lucentis® (ranibizumab
injection)^ is the first treatment approved to improve vision in
people with certain retinal conditions.4
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 (BALATON) [Internet; cited January
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 January 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931.
[3] U.S. Food and Drug Administration (FDA). Highlights of
prescribing information, Aflibercept 2 mg. 2011. [Internet; cited
January 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf.
[4] U.S. FDA. Highlights of prescribing information, Lucentis.
2006. [Internet; cited January 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125156s105lbl.pdf.
[5] U.S National Institutes of Health - National Eye Institute.
Macular Edema. 2023. [Internet; cited January 2024.] Available
from:
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema.
[6] U.S. FDA. Highlights of prescribing information, Vabysmo. 2022.
[Internet; cited January 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
[7] MHRA approves faricimab through international work-sharing
initiative [Internet; cited January 2024]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[8] 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 III, non-inferiority trials. The
Lancet. 2022;399:729-740.
[9] 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.
[10] Roche data on file.
[11] 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.
[12] Moorfields Eye Hospital, United Kingdom National Health
Service Foundation Trust. RVO [Internet; cited January 2024].
Available
from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion.
[13] 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.
[14] Regula JT, et al. Targeting key angiogenic pathways with a
bispecific CrossMab optimized for neovascular eye diseases. EMBO
Molecular Medicine. 2016;8:1265–88.
[15] 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.
[16] Campochiaro P. Molecular pathogenesis of retinal and choroidal
vascular diseases. Prog Retin Eye Res. 2015;49:67-81.
[17] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with nAMD (AVONELLE-X)
[Internet; cited January 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04777201.
[18] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with DME (Rhone-X)
[Internet; cited January 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04432831.
[19] Clinical Trials.gov. A study to investigate faricimab
treatment response in treatment-naïve, underrepresented patients
with DME (ELEVATUM). [Internet; cited January 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT05224102.
[20] 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 January 2024]. Available
from: https://2022.apvrs.org/abstract/?code=200351.
[21] 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.
[22] Chugai obtains regulatory approval for Vabysmo, the first
bispecific antibody in ophthalmology, for neovascular age-related
macular degeneration and diabetic macular edema [Internet; cited
January 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[23] European Medicines Agency. Summary of Product Characteristics,
Vabysmo, 2022 [Internet; cited January 2024]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[24] U.S. FDA. Highlights of prescribing information, Susvimo. 2006
[Internet; cited January 2024]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
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