Positive topline phase III results show Roche's Vabysmo improved
vision for people living with retinal vein occlusion (RVO)
- Vabysmo
achieved its primary endpoint of non-inferiority
to aflibercept in RVO in the
BALATON and COMINO clinical trials
- Vabysmo
was generally well tolerated, with a safety profile
consistent with previous trials
- Vabysmo is
the first and only treatment that targets and inhibits two disease
pathways involving Ang-2 and VEGF-A, linked to a number of
vision-threatening retinal conditions
- Detailed results will be
presented at an upcoming medical meeting and submitted to
regulatory authorities around the world
Basel, 27 October 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
today announced positive topline results from two global phase III
studies, BALATON and COMINO, evaluating the first and only
bispecific antibody for the eye, Vabysmo® (faricimab), in macular
edema due to branch and central retinal vein occlusion (BRVO and
CRVO).1,2,3 RVO is a vision-threatening condition that impacts 28
million people globally.4
Both studies met their primary endpoints, showing that people
with macular edema due to BRVO and CRVO receiving Vabysmo
injections every four weeks, for up to 24 weeks, achieved
non-inferior visual acuity gains compared to those receiving
aflibercept injections every four weeks.
“These encouraging data demonstrate that Vabysmo could
potentially provide a new treatment option for people living with
retinal vein occlusion, a serious retinal vascular condition that
can lead to irreversible vision impairment or vision loss,” said
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head
of Global Product Development. “Today’s results add to the
extensive evidence supporting Vabysmo’s efficacy in treating
multiple types of retinal conditions. We look forward to submitting
these data to regulatory authorities.”
Vabysmo also showed rapid drying of retinal fluid from baseline
through week 24, as measured by reduction in central subfield
thickness.
In both studies, Vabysmo was generally well tolerated. The
safety profile was consistent with previous trials.
Detailed results will be presented at an upcoming medical
meeting and submitted to regulatory authorities around the
world.
Vabysmo is uniquely engineered to target and inhibit two disease
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.3,5 The level of Ang-2 is elevated in RVO and it is
thought that increased Ang-2 expression drives disease
progression.6,7
To date, Vabysmo is approved in more than 40 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 (nAMD) and diabetic macular edema
(DME).8,9,10,11,12 Vabysmo’s long-term efficacy and safety in nAMD
and DME has been demonstrated by two-year data from four large,
global studies involving more than 3,000 participants.3,5,13,14
Vabysmo is the only injectable eye medicine approved with phase III
studies supporting treatment intervals of up to four months for
people living with nAMD and DME.12 Globally, more than 165,000
Vabysmo doses have been distributed for treatment of these
conditions to date.8 RVO, nAMD and DME together affect around 70
million people worldwide and are among the leading causes of vision
loss.3,4,15,16,17
About retinal vein occlusion (RVO)RVO is the
second most common cause of vision loss due to retinal vascular
diseases.4 It affects an estimated 28 million adults globally,
mainly those aged 60 or older, and can lead to severe and sudden
vision loss.4,18 The level of angiopoietin-2 (Ang-2) is elevated in
RVO and it is thought that increased Ang-2 expression drives
disease progression.6,7 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.18,19,20 Currently, macular edema due to RVO is typically
treated with repeated intravitreal injections of anti-vascular
endothelial growth factor therapies.20 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.4,20
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 are 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 receive Vabysmo (6.0 mg) up to every four
months – according to a personalised treatment interval dosing
regimen – using a treat-and-extend approach.
The BALATON study is being conducted in 553 people with branch
retinal vein occlusion. The COMINO study is being conducted in 729
people with central retinal or hemiretinal vein occlusion.
The primary endpoint of each study is the change in
best-corrected visual acuity from baseline at 24 weeks. Secondary
endpoints include change in central subfield thickness and drying
of retinal fluid from baseline over time up to week 24.
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, and RHONE-X,
an extension study of YOSEMITE and RHINE evaluating the long-term
safety and tolerability of Vabysmo in diabetic macular edema
(DME).21,22 Roche has also initiated the phase IV ELEVATUM study of
Vabysmo in underrepresented patient populations with DME 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.9,11 It targets
and inhibits two disease 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.3,5 By blocking pathways involving
Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood
vessels.3,5 Vabysmo is approved in more than 40 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.8,9,10,11,12
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.24 Vabysmo® (faricimab) is the
first bispecific antibody approved for the eye, which targets two
disease pathways that drive retinal conditions.3,5,9,11 Lucentis®
(ranibizumab injection) is the first treatment approved to improve
vision in people with certain retinal conditions.25About
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
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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] 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 2022]. 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 2022]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931[3] Heier JS, et al.
Efficacy, durability, and safety of intravitreal faricimab up to
every 16 weeks for neovascular age-related macular degeneration
(nAMD) (TENAYA and LUCERNE): two randomised, double-masked, phase
III, non-inferiority trials. The Lancet. 2022; 399:729-740.[4] 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;9:010427.[5] Wykoff C, et al.
Efficacy, durability and safety of intravitreal faricimab with
extended dosing up to every 16 weeks in patients with diabetic
macular edema (DME) (YOSEMITE and RHINE): two randomised,
double-masked, phase III trials. The Lancet. 2022; 399:741-755.[6]
Regula JT, et al. Targeting key angiogenic pathways with a
bispecific CrossMab optimised for neovascular eye diseases. EMBO
Molecular Medicine. 2016;8:1265–88.[7] Joussen AM, et al.
Angiopoietin/Tie2 signalling and its role in retinal and choroidal
vascular diseases: a review of preclinical data. Eye.
2021;35:1305-1316. [8] Roche data on file.[9] United States Food
and Drug Administration (U.S. FDA). Highlights of prescribing
information, Vabysmo. 2022 [Internet; cited October 2022].
Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf[10]
Chugai Pharmaceutical Co. Ltd. Chugai obtains regulatory approval
for Vabysmo, the first bispecific antibody in ophthalmology, for
nAMD and DME [Internet; cited October 2022]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html[11]
Medicines and Healthcare products Regulatory Agency (MHRA). MHRA
approves faricimab through international work-sharing initiative
[Internet; cited October 2022]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative[12]
European Medicines Agency. Summary of Product Characteristics,
Vabysmo, 2022 [Internet; cited October 2022]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf[13]
Wells JA, et al. Faricimab in DME: two-year results from the phase
III YOSEMITE and RHINE trials. Presented at: Angiogenesis,
Exudation and Degeneration 2022; 11-12 February 2022; virtual.[14]
Khanani A, et al. Faricimab in nAMD: year 2 efficacy, safety and
durability results from the phase III TENAYA and LUCERNE trials.
Presented at: 2022 American Society of Retina Specialists Annual
Scientific Meeting; 13-16 July 2022; New York City, NY, USA. [15]
Yau JWY, et al. Global prevalence and major risk factors of
diabetic retinopathy. Diabetes Care. 2012;35:556–64.[16] Connolly
E, et al. Prevalence of age-related macular degeneration associated
genetic risk factors and four-year progression data in the Irish
population. Br J Ophthalmol. 2018;102:1691-95.[17] Bright Focus
Foundation. Age-related macular degeneration: facts and figures
[Internet; cited October 2022]. Available from:
https://www.brightfocus.org/macular/article/age-related-macular-facts-figures[18]
Moorfields Eye Hospital, United Kingdom National Health Service
Foundation Trust. RVO [Internet; cited October 2022]. Available
from:
https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion[19]
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. [20] Campochiaro P.
Molecular pathogenesis of retinal and choroidal vascular diseases.
Prog Retin Eye Res. 2015;49:67-81.[21] Clinical Trials.gov. A study
to evaluate the long-term safety and tolerability of Vabysmo in
participants with nAMD (AVONELLE-X) [Internet; cited October 2022].
Available from: https://clinicaltrials.gov/ct2/show/NCT04777201[22]
Clinical Trials.gov. A study to evaluate the long-term safety and
tolerability of Vabysmo in participants with DME (Rhone-X)
[Internet; cited October 2022]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04432831[23] Clinical
Trials.gov. A study to investigate faricimab treatment response in
treatment-naïve, underrepresented patients with DME (ELEVATUM).
[Internet; cited October 2022]. Available from:
https://clinicaltrials.gov/ct2/show/NCT05224102[24] U.S. FDA.
Highlights of prescribing information, Susvimo. 2006 [Internet;
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U.S. FDA. Highlights of prescribing information, Lucentis. 2006
[Internet; cited October 2022]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf
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