Roche to reintroduce Susvimo in the US for people with neovascular
age-related macular degeneration (nAMD)
- The FDA has approved
updates to Susvimo, which will be available to US retina
specialists and patients with nAMD in the coming
weeks
- Susvimo offers the first
alternative to regular eye injections that are standard of care for
nAMD, which impacts 20 million people worldwide and can cause
blindness if left untreated
- By continuously delivering
medicine to the eye through a refillable implant, Susvimo is the
first and only approved nAMD treatment shown to maintain vision
with two refills a year
Basel, 08 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the reintroduction of Susvimo® (ranibizumab
injection) 100 mg/mL for intravitreal use via ocular implant for
the treatment of people in the United States (US) with neovascular
or ‘wet’ age-related macular degeneration (nAMD), following the end
of a voluntary recall. The US Food and Drug Administration (FDA)
has approved a post-approval supplement to the Biologics License
Application for Susvimo, reflecting component-level updates made to
the ocular implant and refill needle. Roche will work to make
Susvimo available in the US to retina specialists and their
patients with nAMD in the coming weeks.
“We are pleased to reintroduce Susvimo, a unique therapeutic
approach shown to provide an effective alternative to regular eye
injections by preserving vision with two refills per year in Phase
III study patients with neovascular age-related macular
degeneration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief
Medical Officer and Head of Global Product Development. “Susvimo’s
return to the retina community reflects our unwavering commitment
to provide innovative retinal treatments, and lays the groundwork
for future advancements.”
Susvimo provides continuous delivery of a customised formulation
of ranibizumab via the Port Delivery Platform, while other
currently approved treatments may require multiple eye injections
per year.1-3
The Susvimo implant is surgically inserted into the eye during a
one-time, outpatient procedure and is refilled once every six
months using a specifically designed needle, which introduces a
customised formulation of ranibizumab directly into the
device.1,4 Susvimo was approved by the FDA in
2021.4 The following year, Roche voluntarily recalled
the ocular implant, insertion tool and initial fill kit in the US
following test results that showed some implants did not perform to
Roche’s standards. Roche has since updated the Susvimo implant and
refill needle, and testing confirmed that they now meet these
performance standards.5 Manufacturing process
improvements were also implemented.5
Roche is committed to making this innovative drug delivery
system available around the world. This is one of multiple options
Roche continues to develop to meet the needs of people living with
nAMD and other prevalent eye conditions, including diabetic macular
edema.
About neovascular age-related macular
degeneration
Age-related macular degeneration (AMD) is a condition that affects
the part of the eye that provides sharp, central vision needed for
activities like reading.6 Neovascular or ‘wet’ AMD
(nAMD) is an advanced form of the disease that can cause rapid and
severe vision loss if left untreated.7,8 It
develops when new and abnormal blood vessels grow uncontrolled
under the macula, causing swelling, bleeding and/or
fibrosis.8 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.6,9,10
About Susvimo® (Port Delivery System
with ranibizumab)
Susvimo is a refillable eye implant surgically inserted into the
eye during a one-time, outpatient procedure. Susvimo continuously
delivers a customised formulation of ranibizumab over
time.1 Ranibizumab is a vascular endothelial growth
factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a
protein that has been shown to play a critical role in the
formation of new blood vessels and the leakiness of the
vessels.11
The customised formulation of ranibizumab delivered by Susvimo
is different from the ranibizumab intravitreal injection, a
medicine marketed as Lucentis®* (ranibizumab injection), which is
approved to treat neovascular or ‘wet’ age-related macular
degeneration (nAMD) and other retinal diseases. Lucentis* was first
approved for nAMD by the US Food and Drug Administration in
2006.3
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 United States (US) Food and Drug Administration in
2021.4 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 and vascular
endothelial growth factor-A.12,13 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.5,14-18 Lucentis®
(ranibizumab injection)* was the first treatment approved to
improve vision in people with certain retinal
conditions.3
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] Holekamp N, et al. Archway randomised Phase III trial of the
Port Delivery System with ranibizumab for neovascular age-related
macular degeneration (nAMD). Ophthalmology. 2021.
[2] U.S. Food and Drug Administration (FDA). Highlights of
prescribing information, aflibercept 2 mg. 2022. [Internet; cited
July 2024]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125387s076lbl.pdf.
[3] U.S. FDA. Highlights of prescribing information, Lucentis.
2014. [Internet; cited July 2024]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.
[4] U.S.FDA. Highlights of prescribing information, Susvimo. 2021.
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[5] Roche data on file.
[6] Bright Focus Foundation. Age-related macular degeneration
(AMD): facts & figures. [Internet; cited July 2024]. Available
from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.
[7] Pennington KL, et al. Epidemiology of AMD: associations with
cardiovascular disease phenotypes and lipid factors. Eye and
Vision. 2016;3:34.
[8] Little K, et al. Myofibroblasts in macular fibrosis secondary
to nAMD - the potential sources and molecular cues for their
recruitment and activation. EBioMedicine. 2018;38:283-91.
[9] Connolly E, et al. Prevalence of AMD associated genetic risk
factors and four-year progression data in the Irish population.
British Journal of Ophthalmology. 2018 Feb;102:1691-95.
[10] Wong WL, et al. Global prevalence of AMD and disease burden
projection for 2020 and 2040: a systematic review and
meta-analysis. The Lancet Global Health. 2014 Feb;2:106-16.
[11] Heier JS, et al. The angiopoietin/tie pathway in retinal
vascular diseases: a review. The Journal of Retinal and Vitreous
Diseases. 2021;41:1-19.
[12] 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; 399:729-40.
[13] 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.
[14] U.S.FDA. Highlights of prescribing information, Vabysmo. 2022.
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
[15] Medicines and Healthcare products Regulatory Agency approves
faricimab through international work-sharing initiative. [Internet;
cited July 2024]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[16] Chugai obtains regulatory approval for Vabysmo, the first
bispecific antibody in ophthalmology, for nAMD and DME. [Internet;
cited July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[17] European Medicines Agency. Summary of product characteristics,
Vabysmo. 2022. [Internet; cited July 2024]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[18] Chugai obtains regulatory approval for Vabysmo, the only
bispecific antibody in the ophthalmology field, for additional
indication of macular edema associated with retinal vein occlusion.
[Internet; cited July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
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