Roche’s Vabysmo showed extended durability, continued efficacy and
a consistent safety profile in long-term diabetic macular edema
(DME) study
- More than 90% of patients had absence
of DME after four years in a pre-specified exploratory
endpoint
- People treated with Vabysmo sustained vision gains and
anatomical improvements, with almost 80% receiving treatment at
intervals of three or four months, in an exploratory
analysis
- The study met all primary endpoints, showing safety
data were consistent with Vabysmo’s known safety
profile
- This is the largest long-term extension dataset in DME
to-date, demonstrating consistent positive results in a highly
prevalent eye condition
Basel, 17 July 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today new, four-year data from the RHONE-X extension
study.1 The study met all primary endpoints, showing
that Vabysmo® (faricimab) was well tolerated in people with
diabetic macular edema (DME) who received treatment for up to four
years.2 Exploratory results from the long-term study
showed that Vabysmo continued to preserve vision, dry retinal fluid
that can impair sight, and allow extended time between treatments
in people with DME.2 These data were presented in a
late-breaking oral presentation at The American Society of Retina
Specialists (ASRS) 2024 Annual Meeting in Stockholm,
Sweden.2
“These four-year data build on our pivotal studies and reinforce
Vabysmo’s potential to become standard of care treatment for
diabetic macular edema (DME), which affects 29 million people
worldwide,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical
Officer and Head of Global Product Development. “We are especially
pleased to see that 9 out of 10 patients showed no sign of DME
after four years of treatment with Vabysmo, which is an incredible
long-term outcome for people living with this condition.”
The RHONE-X study is the largest long-term extension dataset in
DME, a leading cause of vision loss in people with
diabetes.3,4
“I have been using Vabysmo as a first-line treatment for all the
approved indications, including diabetic macular edema, and the
positive long-term safety and efficacy results from the RHONE-X
study are consistent with my clinical experience for over two
years,” said study investigator Arshad M. Khanani, M.D., Director
of Clinical Research at Sierra Eye Associates and Clinical
Professor at the University of Nevada, Reno, who presented the data
at the ASRS.
During RHONE-X, all participants were treated with Vabysmo on a
personalised treat-and-extend regimen, where the time between
Vabysmo treatments could be increased based on retinal fluid levels
and visual acuity. Results of the exploratory analysis showed that
at the end of four years, nearly 80% of participants treated with
Vabysmo had extended their treatment intervals to every three or
four months. Additionally, people treated with Vabysmo maintained
the vision improvements and sustained the drying of retinal fluid
they achieved during the initial Phase III studies (YOSEMITE and
RHINE). In a pre-specified exploratory endpoint, more than 90% of
people treated with Vabysmo achieved absence of DME, defined as
central subfield thickness (CST) less than 325 microns.2
CST is a measure of swelling from fluid in the back of the eye
caused by unstable, leaky blood vessels; reducing CST indicates
retinal drying.
To date, Vabysmo is approved in nearly 100 countries for DME and
neovascular or ‘wet’ age-related macular degeneration
(nAMD).3,5-8 It is also approved in several countries,
including the United States and Japan, for the treatment of macular
edema following retinal vein occlusion.3,5,9 More than
four million doses of Vabysmo have been distributed worldwide since
its initial US approval in 2022.3
About RHONE-X1
RHONE-X is a multicentre two-year extension study designed to
evaluate the long-term safety and tolerability of Vabysmo®
(faricimab) in 1,474 patients with diabetic macular edema who
completed one of the two Phase III studies, YOSEMITE (NCT03622580)
or RHINE (NCT03622593).10,11 Patients in YOSEMITE and
RHINE were treated with either Vabysmo or 2 mg aflibercept.
Patients in RHONE-X were all treated with Vabysmo according to a
personalised treatment interval.
The primary objectives were to evaluate the long-term safety and
tolerability of Vabysmo, including ocular adverse events (AEs),
non-ocular AEs and presence of anti-drug antibodies. The study also
had an exploratory objective to assess the long-term efficacy of
Vabysmo.
About diabetic macular edema
Affecting around 29 million people globally, diabetic macular edema
(DME) is a vision-threatening retinal condition associated with
blindness and decreased quality of life when left
untreated.12,13 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.14,15 The number of people with DME is expected
to grow as the prevalence of diabetes increases.16
About the Vabysmo® (faricimab) clinical development
programme
Roche has a robust Phase III clinical development programme for
Vabysmo. The programme includes AVONELLE-X (NCT04777201), an
extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300),
evaluating the long-term safety and tolerability of Vabysmo in
neovascular or ‘wet’ age-related macular degeneration
(nAMD).17 Roche has also initiated several Phase IV
studies, including the ELEVATUM (NCT05224102) study of Vabysmo in
underrepresented patient populations with diabetic macular edema,
the SALWEEN study of Vabysmo in a subpopulation of nAMD highly
prevalent in Asia, and the POYANG (NCT06176352) study of
Vabysmo in adult treatment-naive patients with choroidal
neovascularisation secondary to pathologic myopia.18-20
Roche has also initiated the VOYAGER (NCT05476926) study, a global
real-world data collection platform, and supports several other
independent studies to further understand retinal conditions with a
high unmet need.21
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the
eye.5,22 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.22,23 Vabysmo is approved in nearly 100
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 the treatment of macular edema following retinal
vein occlusion.3,5,9 Review by other health 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 is
the first United States (US) Food and Drug Administration-approved
refillable eye implant for neovascular or ‘wet’ age-related macular
degeneration (nAMD) that continuously delivers a customised
formulation of ranibizumab over a period of months.24,25
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.5,22,23 Vabysmo is approved around the world
for people living with nAMD and diabetic macular edema, and in
several countries, including the US and Japan, for macular edema
following retinal vein occlusion.3,5-9 Lucentis®
(ranibizumab injection)* was the first treatment approved to
improve vision in people with certain retinal
conditions.26
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] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with diabetic macular
edema (DME) (RHONE-X). [Internet; cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04432831.
[2] Khanani, A.M. (2024, July 17). Four-year outcomes of faricimab
in DME: First-time safety and efficacy results from the RHONE-X
long-term extension trial. The American Society of Retina
Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.
[3] Roche data on file.
[4] Lee, R., Wong, T.Y. & Sabanayagam, C. Epidemiology of
diabetic retinopathy, DME and related vision loss. Eye and Vision
2, 17 (2015). https://doi.org/10.1186/s40662-015-0026-2.
[5] United States (US) Food and Drug Administration (FDA).
Highlights of prescribing information, Vabysmo. 2022. [Internet;
cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.
[6] 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.
[7] 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.
[8] Chugai obtains regulatory approval for Vabysmo, the first
bispecific antibody in ophthalmology, for neovascular or ‘wet’
age-related macular degeneration (nAMD) and DME. [Internet; cited
July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[9] 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
(RVO). [Internet; cited July 2024]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[10] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with DME (YOSEMITE). [Internet;
cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT03622580.
[11] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in participants with DME (RHINE). [Internet;
cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT03622593.
[12] Im JHB, et al. Prevalence of DME based on optical coherence
tomography in people with diabetes: a systematic review and
meta-analysis. Survey of Ophthalmology. 2022
Jul-Aug;67(4):1244-1251.
[13] The Lancet. Diabetes: A defining disease of the 21st century.
Lancet. 2023 24;401(10394):2087.
[14] All About Vision. Macula lutea. [Internet; cited July 2024].
Available
from: https://www.allaboutvision.com/resources/macula.
[15] National Eye Institute. Diabetic Retinopathy. [Internet; cited
July 2024]. Available
from: https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy.
[16] Liu E, et al. DME: Clinical risk factors and emerging genetic
influences. Clinical and Experimental Optometry.
2017;100:569–76.
[17] Clinical Trials.gov. A study to evaluate the long-term safety
and tolerability of Vabysmo in participants with nAMD (AVONELLE-X).
[Internet; cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04777201.
[18] Clinical Trials.gov. A study to investigate faricimab
treatment response in treatment-naïve, underrepresented patients
with DME (ELEVATUM). [Internet; cited July 2024]. Available
from: https://clinicaltrials.gov/ct2/show/NCT05224102.
[19] APVRS. Design and rationale of the SALWEEN trial: A Phase
IIIb/IV study of faricimab, a dual angiopoietin-2 and vascular
endothelial growth factor-a inhibitor, in patients with polypoidal
choroidal vasculopathy. [Internet; cited July 2024]. Available
from: https://2022.apvrs.org/abstract/?code=200351.
[20] Clinical Trials.gov. A study to evaluate the efficacy and
safety of faricimab in patients with choroidal neovascularization
secondary to pathologic myopia (POYANG). [Internet; cited July
2024]. Available from:
https://www.clinicaltrials.gov/study/NCT06176352.
[21] Clinical Trials.gov. A real-world study to gain clinical
insights into Roche ophthalmology products (VOYAGER). [Internet;
cited July 2024]. Available from:
https://clinicaltrials.gov/ct2/show/NCT05476926.
[22] 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.
[23] 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.
[24] US FDA. Highlights of prescribing information, Susvimo. 2021.
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[25] Holekamp N, et al. Archway randomised Phase III trial of the
Port Delivery System with ranibizumab for nAMD. Ophthalmology.
2021.
[26] US FDA. Highlights of prescribing information, Lucentis. 2014.
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf.
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