* Vabysmo PFS is the first and only syringe prefilled with an FDA-approved
bispecific antibody to treat retinal conditions that can cause blindness
* Designed to simplify administration, Vabysmo PFS provides retina specialists

    a ready-to-use option
  * Vabysmo PFS will be available for people living with nAMD, DME and RVO

Basel, 05 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the
United States Food and Drug Administration (US FDA) has approved the Vabysmo®
(faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment
of neovascular or 'wet' age-related macular degeneration (nAMD), diabetic
macular edema (DME) and macular edema following retinal vein occlusion (RVO).
Together, these three conditions affect close to 80 million people globally.(1-
4) The Vabysmo PFS will become available to United States (US) retina
specialists and their patients in the coming months.
"We are pleased that the US FDA has approved the Vabysmo PFS for people living
with neovascular age-related macular degeneration, diabetic macular edema and
retinal vein occlusion, which are some of the leading causes of vision loss,"
said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of
Global Product Development. "While many retina specialists are already using
Vabysmo as a first-line treatment, this new offering should make it even simpler
to administer, thereby enhancing the treatment experience for both physicians
and patients."
Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials
in an alternative, ready-to-use format. Vabysmo will continue to be available in
a 6.0 mg vial.(5)
Vabysmo is the first and only bispecific antibody approved for the eye and has
demonstrated rapid and robust vision improvements and retinal drying in nAMD,
DME and RVO.(5-13) Retinal drying is an important clinical measure, as swelling
from excess fluid in the back of the eye is associated with distorted and
blurred vision.(14)
To date, Vabysmo is approved in more than 95 countries for nAMD and DME, and in
several countries, including the US and Japan, for RVO.(5)(,7,15)(-18) Review by
other health authorities across the globe is ongoing. More than four million
doses of Vabysmo have been distributed globally since its initial US approval in
2022.(18)
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.(5-7 )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.(6,19) Vabysmo is approved in
more than 95 countries around the world, including the United States (US),
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 several countries, including the US and Japan, for retinal vein
occlusion.(5,7,15-19 )Review by other regulatory authorities is ongoing.
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 Food and Drug Administration in
2021.(20) 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.(5-7,19) Lucentis® (ranibizumab injection)*
was the first treatment approved to improve vision in people with certain
retinal conditions.(21)
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.
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70K7TDrJPfsPtVA1hpP6KXXY6RBXleRqlKmLhEZOsw=).
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cwh_mdfsVI5B-JgfFfSzCGzOPrzHOvNDl-
zax9EbYZbVcxJKH6NOcMw13IM0boFFXU2uTrAZyKKjOW3PEHWsUD5XYMRh3_3muAXHWsh4pQOc0jYCJZ
gtej0YmgW-MCMg3ySyxAQ=).
(12)Clinical Trials.gov. A study to evaluate the efficacy and safety of
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(https://www.globenewswire.com/Tracker?data=L96r-
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Ws7gW8iR6aGrgumcYOH6yIKb64yVjt1TLmSxSYD017EbC4r9_-
miOCd_loM6fxifZ_MWbFmnD1z0n10uAwGO1_zRXho=).
(13) Clinical Trials.gov. A study to evaluate the efficacy and safety of
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(https://www.globenewswire.com/Tracker?data=L96r-
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OJHW6netNpqAHOL7UDP7YEneeawSlRbHM=).
(14) United States National Institutes of Health - National Eye Institute.
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https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-
diseases/macular-edema
(https://www.globenewswire.com/Tracker?data=nVDXUkhuLuIEkOewi9uuSeZo51UEONOpzbNE
N-90ASqjqPRk4eiqsAMn1BJtbicSE3QIw48B4Of2qr-GVL9UoPD-iLMRgOw9oV5P14Ri9b_Red_AIH-
u0ZZe96kCTrNCeKyotQnv4N_psaSA9FdPuNNL1zzCOmNzcdDQTDjkTHi6MZwn6kZ60KS45-
ZhSpQZvSPyiHq12oXQypMdKHMHr0Cy03ZRNaMn-v0yD6QZ7STnxvRujRud2502C_-
bBbBG60MzLtWvB6GWmD7-_x9xQw==).
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pharm.co.jp/english/news/detail/20220328160002_909.html.
(16) Chugai obtains regulatory approval for Vabysmo, the only bispecific
antibody in the ophthalmology field, for additional indication of macular edema
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(17) European Medicines Agency. Summary of product characteristics, Vabysmo.
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information_en.pdf.
(18) Roche data on file.
(19) 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.
(20) U.S. FDA. Highlights of prescribing information, Susvimo. 2021. (Internet;
cited July 2024). Available from:
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(21) U.S. FDA. Highlights of prescribing information, Lucentis. 2014. (Internet;
cited July 2024). Available from:
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f (https://www.globenewswire.com/Tracker?data=TSJoXdQK-5HZLJCp6eGApNE2YpVON-
YVOk9N7MTWJEES9qtzFSo84k0hvberHUWcJ82A-
oK7gRdvuG3ojssIAvkrvDu2KARH_rkWPIjDVKsaYSsyrDtaGsd0Q1_BDaMMf4dF3CFK_lFmVQX3F1YgZ
L7MUBBEP2dGLwtHCas7Q94GbHuwFRdhZCwVmIraWB-
XcF6wI_hL0hQWgW9cEAvab5JgxXddnny9ijdXGCAvYBJZyxkaRLTNazQvSvEyMIyd).
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