New clinical and real-world data for Roche’s Vabysmo at ASRS reveal
improved outcomes for people with two leading causes of vision loss
- Late-breaking post-hoc data
indicate Vabysmo leads to less
fibrosis, which may negatively impact vision, than
aflibercept in people with diabetic
macular edema (DME)
- Real-world data reinforce
that first-line Vabysmo use
improves outcomes and extends treatment intervals rapidly during
the first four months for people with
neovascular or ‘wet’ age-related macular
degeneration (nAMD) and
DME
- Clinical data
reiterate Vabysmo’s positive
anatomical outcomes, including reduced blood vessel leakage in the
macula and greater and faster retinal fluid control
- Vabysmo is
currently approved in over 70 countries to treat
nAMD and DME, with more than one million
doses distributed globally
Basel, 20 July - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced
today that data from its ophthalmology portfolio will be
highlighted in 25 abstracts at the 2023 American Society of Retina
Specialists (ASRS) Annual Meeting, which will be held from 28 July
to 1 August in Seattle, United States. The data further advance the
depth of clinical and real-world evidence supporting the use of
Vabysmo® (faricimab), the first and only bispecific antibody for
the eye, for the treatment of neovascular or ‘wet’ age-related
macular degeneration (nAMD) and diabetic macular edema
(DME).1-14
“The clinical and real-world data at ASRS reinforce the
improvement in outcomes brought by Vabysmo in two leading causes of
vision loss, particularly new analyses suggesting that Vabysmo is
associated with less vision-impacting fibrosis than aflibercept,”
said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and
Head of Global Product Development. “By improving disease control
while offering a potentially less frequent treatment regimen,
Vabysmo may help people spend less time managing their
condition.”
Vabysmo is currently approved in over 70 countries to treat nAMD
and DME, with public reimbursement in over 20 markets and more than
one million doses distributed globally.15 Neovascular AMD and DME
are two leading causes of vision loss worldwide, affecting more
than 40 million people.16-19
The following key data will be presented at ASRS 2023:
Late-breaker: Vabysmo’s
effect on epiretinal
membrane (ERM) formation in DME compared to
aflibercept
Two-year post-hoc data from the YOSEMITE and RHINE phase III
studies will be presented for the first time on ERM formation in
DME patients, indicating Vabysmo leads to less retinal fibrosis
than aflibercept.3 ERMs are fibrotic tissues on the surface of the
retina, which may negatively impact the anatomy of the eye and
compromise vision.20
Vabysmo drying and durability
data
Data will be presented reiterating positive anatomical outcomes
previously seen with Vabysmo treatment, including reduced blood
vessel leakage in the macula, and greater and faster retinal fluid
control.4,6,7 Blood vessel leakage can cause a build-up of fluid
and swelling in the back of the eye, contributing to sight
loss.21,22
Data will also further support how increased intervals between
doses of Vabysmo to treat nAMD and DME, compared to aflibercept, do
not compromise outcomes.4,6,7
Vabysmo real-world data
Roche’s expanding programme of real-world studies for Vabysmo
includes more than 8,500 participants in almost 30 countries.15
- Updates will be presented on real-world data from the FARETINA
studies of Vabysmo in nAMD and DME looking at extended dosing
intervals and impact on vision, including Vabysmo’s use as a
first-line treatment.9,10
- Preliminary data on early outcomes
and treatment patterns in the United Kingdom FARWIDE studies of
Vabysmo in nAMD and DME will be shared for the first
time.11,12
In addition, independent investigator studies of Vabysmo are
expected to be presented. The TRUCKEE study, which focused on
real-world outcomes in people with nAMD across 14 sites in the
United States is scheduled for presentation on 31 July during the
Wet AMD Symposium 3 (1:38 PM to 1:44 PM PDT).23
Further information on select Roche abstracts that will be
presented at ASRS 2023 can be found in the table below.
Topic |
Abstract Title |
Presentation Details |
Vabysmo |
An Assessment of the Impact of Disease Activity Criteria on Dosing
Interval Assignment in Clinical Trial Patients With
nAMD |
Paper PresentationSession: Wet AMD Symposium 1July 29, 20238:49 AM
to 8:53 AM PDT |
Elevatum Study Design and Rationale: A Phase 4 Trial of Faricimab
(VABYSMO) in Underrepresented Patients With Diabetic Macular
Edema |
Paper PresentationSession: Diabetic Retinopathy Symposium 2July 30,
20232:04 PM to 2:07 PM PDT |
Impact of Faricimab vs Aflibercept on Epiretinal Membrane Formation
Over 2 Years in Eyes with DME in the YOSEMITE/RHINE Phase 3
Trials |
Paper PresentationSession: Late Breaking AbstractsJuly 30, 20233:58
PM to 4:03 PM PDT |
Faricimab Reduces Macular Leakage vs Aflibercept in Patients With
DME |
Paper PresentationSession: Diabetic Retinopathy Symposium 3July 31,
202310:53 AM to 10:57 AM PDT |
Faricimab Causes Rapid and Sustained Intraocular Suppression of
Ang-2 and VEGF-A for Up to 16 Weeks in nAMD and DME |
Paper PresentationSession: Diabetic Retinopathy Symposium 3July 31,
202310:57 AM to 11:01 AM PDT |
Time to Retinal Fluid Control With Faricimab vs Aflibercept in
Patients With DME in the Phase 3 YOSEMITE/RHINE Trials |
Paper PresentationSession: Diabetic Retinopathy Symposium 3July 31,
202311:01 AM to 11:05 AM PDT |
Faricimab Rapidly Improves Fluid Parameters in Patients With
nAMD |
Paper PresentationSession: Wet AMD Symposium 3July 31, 20231:30 PM
to 1:34 PM PDT |
Efficacy, Durability, and Safety of Faricimab in DME: 1-year
Results from China Subpopulation of Phase 3 RHINE Trial |
Virtual Paper on Demand Presentation |
Vabysmo Real-World
Data |
Early Treatment Patterns and Outcomes in Patients with Diabetic
Macular Edema Treated with Faricimab: the FARETINA-DME Study |
Paper PresentationSession: Diabetic Retinopathy Symposium 3 July
31, 202311:05 AM to 11:09 AM PDT |
Early Treatment Patterns and Outcomes in Patients with Neovascular
Age-Related Macular Degeneration Initiating Faricimab: the
FARETINA-AMD Study |
Paper PresentationSession: Wet AMD Symposium 3July 31, 20231:34 PM
to 1:38 PM PDT |
Real-world Use of Faricimab to Treat nAMD Patients in the UK |
Virtual Paper on Demand Presentation |
Real-world Use of Faricimab to Treat DME Patients in the UK |
Poster Presentation |
Susvimo |
Port Delivery System With Ranibizumab (PDS) for Continuous
Treatment in DME and DR: Additional Results From the Phase 3 Pagoda
and Pavilion Trials |
Paper Presentation Session:Late Breaking AbstractsAugust 1,
202310:53 AM to 10:59 AM PT |
Anti-IL-6 (for Uveitic
Macular Edema) |
A Novel Intravitreal Anti-IL-6 Monoclonal Antibody for Uveitic
Macular Edema (UME): Preliminary Results From the Phase 1 DOVETAIL
Study |
Paper PresentationSession: Inflammatory & Infectious Diseases
SymposiumJuly 29, 20234:04 PM to 4:10 PM PDT |
About neovascular
age-related macular degenerationAge-related
macular degeneration (AMD) is a condition that affects the part of
the eye that provides sharp, central vision needed for activities
like reading.16 Neovascular or ‘wet’ AMD (nAMD) is an advanced form
of the disease that can cause rapid and severe vision loss if left
untreated.24,25 It develops when new and abnormal blood vessels
grow uncontrolled under the macula, causing swelling, bleeding
and/or fibrosis.24 Worldwide, around 20 million people are living
with nAMD – the leading cause of vision loss in people over the age
of 60 – and the condition will affect even more people around the
world as the global population ages.16-18
About diabetic macular edemaAffecting around 21
million people globally, diabetic macular edema (DME) is a
vision-threatening retinal condition associated with blindness and
decreased quality of life when left untreated.19 DME occurs when
damaged blood vessels leak into and cause swelling in the macula –
the central area of the retina responsible for the sharp vision
needed for reading and driving.21,26 The number of people with DME
is expected to grow as the prevalence of diabetes increases.27
About the Vabysmo®
(faricimab) clinical
development programmeRoche has a robust
phase III clinical development programme for Vabysmo® (faricimab).
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).28,29 In addition, Roche is investigating the
efficacy and safety of Vabysmo in people with macular edema
following retinal vein occlusion in two phase III studies, BALATON
and COMINO.30,31 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.32-34
Roche also supports several other independent studies to further
understand retinal conditions with a high unmet need.15
About
Vabysmo®
(faricimab)Vabysmo®
(faricimab) is the first bispecific antibody approved for the
eye.13,14 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).35,36 Ang-2 and VEGF-A contribute to vision loss by
destabilising blood vessels, causing new leaky blood vessels to
form and increasing inflammation.35,36 By blocking pathways
involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood
vessels. Vabysmo is approved in over 70 countries around the world,
including the United States, Japan, the United Kingdom and in the
European Union for people living with neovascular or ‘wet’
age-related macular degeneration and diabetic macular
edema.13-15,37,38 Review by other regulatory authorities is
ongoing.
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™ (Port Delivery System with ranibizumab) 100 mg/mL
for intravitreal use via ocular implant is the first U.S. 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.39 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 (Ang-2) and vascular
endothelial growth factor-A (VEGF-A).13,14,35,36 Lucentis®*
(ranibizumab injection) is the first treatment approved to improve
vision in people with certain retinal conditions.40
*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.
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.
All trademarks used or mentioned in this release are protected
by law.References[1] Zarbin M, et al. An
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Elevatum study design and rationale: a phase IIII trial of
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– 1 August 2023.[3] Jaffe GJ, et al. Impact of faricimab vs
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with DME in the YOSEMITE/RHINE phase III trials. Paper presentation
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al. Faricimab reduces macular leakage vs aflibercept in patients
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August 2023.[5] Muni RH, et al. Faricimab causes rapid and
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weeks in nAMD and DME. Paper presentation at: ASRS Annual Meeting;
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fluid control with faricimab vs aflibercept in patients with DME in
the phase III YOSEMITE/RHINE trials. Paper presentation at: ASRS
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faricimab in DME: one-year results from China subpopulation of
phase III RHINE trial. Virtual Paper on Demand Presentation at:
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[21] All About Vision. Macula lutea [Internet; cited July 2023].
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[27] Liu E, et al. DME: clinical risk factors and emerging genetic
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[35] Heier JS, et al. Efficacy, durability, and safety of
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LUCERNE): two randomised, double-masked, phase III, non-inferiority
trials. The Lancet. 2022; 399:729-40.[36] Wykoff C, et al.
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[38] European Medicines Agency. Summary of Product Characteristics,
Vabysmo, 2022 [Internet; cited July 2023]. Available from:
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[39] U.S. FDA. Highlights of prescribing information, Susvimo. 2006
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[40] U.S. FDA. Highlights of prescribing information, Lucentis.
2006 [Internet; cited July 2023]. Available from:
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