* 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 (http://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.pd
f
(https://www.globenewswire.com/Tracker?data=nVDXUkhuLuIEkOewi9uuST_6SYbbTqEui0C2
u0O4GtMjPMPd64MGaDINKkWxtpe6CVUpj5ZIPfwi4ERivFnpAhVHpWJA_RG234lD5exxYvs8AjgWQXMi
j53__4-
Z8CETJCsgZOR8JTP_0kupwWtIg7xKpt230sC7cIr3jJzV2xayS_du0wb1hiUFrbiZgDhZq6ASjyyZv_Y
0Djntu-zJejIjv-9Vs9luc-GXp23hZah7WjoMI9aly9jr2-dboK4s).
(3) U.S. FDA. Highlights of prescribing information, Lucentis. 2014. (Internet;
cited July 2024). Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076
lbl.pdf (https://www.globenewswire.com/Tracker?data=TSJoXdQK-
5HZLJCp6eGApNE2YpVON-YVOk9N7MTWJEES9qtzFSo84k0hvberHUWcJ82A-
oK7gRdvuG3ojssIAvkrvDu2KARH_rkWPIjDVKsaYSsyrDtaGsd0Q1_BDaMMf4dF3CFK_lFmVQX3F1YgZ
L7MUBBEP2dGLwtHCas7Q94GbHuwFRdhZCwVmIraWB-
XcF6wI_hL0hQWgW9cEAvab5JgxXddnny9ijdXGCAvYBJZyxkaRLTNazQvSvEyMIyd).
(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
(https://www.globenewswire.com/Tracker?data=F8ptWLfCENowTpYq9uwzHY8gga6UtSRQQfhN
_SgO5oROlqTAXix4w1XtFZtpRYsB_01gPFWNaLC0dAnSgg0j2xbmFdV41X5a7ICFB5d-
Q2csNN0wKrCp-
MG6HenW6AI18mjkk_UwU62w4M9XW1kCEZ4kYtpFss1V4EwyODhHXHZo2w2BLCQe7Fe4vlJUhLyHLXqA8
rT3B2A5f_EnPmLTlTC6SawKyF3g6xNZPwspDwNB65CqA2snHoMJYKQxWLFd).
(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:
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(https://www.globenewswire.com/Tracker?data=B3q-cW-
tmwgeEKL3N_OqOI9ZhhyjZkAw7mBQUfnNyC9fGGAdS_S5MoNyJxQmVF8a1lwGmVrZY1tvw58g0yIAsY4
tkgTn_yG0EXTzZthNk1RGuFPZdmtx1GVw8gmmk7sidFXtGK2K2jE5OtOHqdhLfaYnnqbjIrXjmh9k5Z5
RulqTewwxO3srmAGxVS2SMEfNvLrFwQmNUHomLTgEWrmXqLHtrp8A0T0H8jpmkIYjnqskUmyjA8pVwFB
t_fgXspA-).
(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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