New data for Roche’s Susvimo demonstrates sustained efficacy in two
serious diabetic eye conditions
- Two-year Phase III data
presented at ASRS 2024 show Susvimo’s potential as an alternative
to eye injections to treat diabetic macular edema (DME) and
diabetic retinopathy (DR)
- Safety data were consistent
with the known safety profile for Susvimo in people with DME and
DR
- Additionally, the US FDA
has accepted the filing application for Susvimo in DME and DR based
on one-year Pagoda and Pavilion study data
- Susvimo is a unique
therapeutic approach that provides continuous delivery of medicine
to the eye through a refillable implant
Basel, 18 July 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced
today two-year data from the Phase III Pagoda and Pavilion studies
evaluating Susvimo® (Port Delivery System with ranibizumab) for the
treatment of diabetic macular edema (DME) and diabetic retinopathy
(DR), respectively, the two leading causes of vision loss in adults
with diabetes.1-4 Susvimo is the first and only
refillable eye implant that provides continuous delivery of a
customised formulation of ranibizumab via the Port Delivery
Platform.5 The results build on the primary one-year
analyses of the Pagoda and Pavilion studies, with Susvimo
demonstrating sustained efficacy over two years and safety
consistent with the known safety profile for Susvimo in people with
DME and DR.6-9 Detailed results were presented at the
American Society of Retina Specialists (ASRS) 2024 Annual Meeting
in Stockholm, Sweden.
Additionally, the United States (US) Food and Drug
Administration (FDA) has accepted Roche’s supplemental Biologics
License Application (sBLA) for Susvimo for the treatment of DME and
DR. The filing acceptance is based on the one-year results from the
Phase III Pagoda and Pavilion studies, which showed that both
studies met their primary endpoint.6,7 To date, Susvimo
is approved in the US for the treatment of neovascular or ‘wet’
age-related macular degeneration (nAMD).10
“These efficacy and safety results demonstrate that Susvimo can
deliver robust vision outcomes over two years for people with
diabetic eye diseases that can cause vision loss,” said Levi
Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of
Global Product Development. “If approved by the US FDA, Susvimo
could bring a new treatment paradigm for diabetic eye diseases. We
hope to bring this option to people with diabetic macular edema and
diabetic retinopathy as soon as possible to help maintain their
vision and potentially their independence.”
One-year primary data supporting US sBLA in DME and
DR6,7
Treatment for DME typically involves regular eye injections every
one to four months.11-13 In Pagoda, people with DME who
received Susvimo refilled every six months achieved non-inferior
visual acuity gains compared with those receiving monthly 0.5 mg
ranibizumab intravitreal injections. Approximately 95% of patients
treated with Susvimo did not need additional treatment with
supplemental injections during the primary analyses study period
(64 weeks). In Pavilion, people with DR who received Susvimo
refilled every nine months achieved superior improvements on the
Diabetic Retinopathy Severity Scale (DRSS) compared with
participants under monthly clinical observation. No individuals
treated with Susvimo needed additional treatment with supplemental
injections during the primary analyses study period (52 weeks),
compared to 60% in the control arm.
Two-year Pagoda and Pavilion results presented at
ASRS8,9
In Pagoda, people with DME receiving Susvimo refilled every six
months through approximately two years (112 weeks) continued to
maintain improvements in vision gains seen at one year (9.8 eye
chart letters). A gain of 9.8 eye chart letters is similar to
gaining two more lines on an eye chart. Approximately 95% of
individuals did not need additional treatment with supplemental
injections. Anatomically, Susvimo showed sustained improvements in
central subfield thickness (CST) through week 112. Reduction in
CST, a measure of retinal drying, is an indicator of swelling from
fluid in the back of the eye caused by unstable, leaky blood
vessels.14 The safety data were consistent with the
known safety profile for Susvimo in people with DME, with no new
safety signals observed. In people treated with Susvimo, no cases
of endophthalmitis were reported up to one year and the rate of
endophthalmitis through week 112 was 0.7%, compared to 0.8% in the
control arm. Refills of Susvimo were resumed in affected
participants after successful resolution of endophthalmitis.
In Pavilion, people with DR receiving Susvimo refilled every
nine months through approximately two years (100 weeks) maintained
DRSS improvements seen at one year. Specifically, at week 100, 80%
of Susvimo participants achieved a two-step or greater improvement
on the DRSS from pre-implant baseline, and participants who
received Susvimo from week 64 either maintained or improved their
DRSS score from pre-implant baseline. A two-step or greater
improvement in the DRSS is a clinically relevant measure of the
decrease in risk for developing vision-threatening complications
secondary to diabetes.15,16 Approximately 98% of
participants treated with Susvimo did not need additional treatment
with supplemental injections. The safety data were consistent with
the known safety profile for Susvimo in people with DR, with no new
safety signals observed. In people treated with Susvimo, no cases
of endophthalmitis were reported up to one year and the rate of
endophthalmitis through week 100 was 0.8%. One participant with DR
developed endophthalmitis and continued receiving treatment with
Susvimo refills after successful resolution.
Roche is focused on saving people’s eyesight from the leading
causes of vision loss through pioneering therapies and has the
broadest retina pipeline in ophthalmology, which is led by science
and informed by insights from people with eye diseases.
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.17,18 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.19,20 The number of people with
DME is expected to grow as the prevalence of diabetes
increases.21
About diabetic retinopathy
Accounting for approximately 5% of all cases of visual impairment,
diabetic retinopathy (DR) occurs when damage to the blood vessels
and the formation of new blood vessels causes blood and/or fluid to
leak into the retina – a part of the eye that sends information to
the brain, enabling sight.22,23 This leads to swelling,
as well as blockage of the blood supply to some areas of the
retina. As the condition progresses, vision becomes
impaired.22,23 DR affects approximately 103 million
people globally, resulting in blindness in almost five million
people.24
About the Pagoda
study1
Pagoda (NCT04108156) is a multicentre, randomised, active
treatment-controlled, non-inferiority US-based Phase III study
evaluating the efficacy, safety and pharmacokinetics of Susvimo®
(Port Delivery System with ranibizumab) refilled every six months
compared with monthly ranibizumab 0.5 mg intravitreal injections,
in 634 people with diabetic macular edema. Participants were
randomised 3:2 to receive either Susvimo refilled every six months
or continued monthly intravitreal ranibizumab injections. In the
Susvimo arm, participants received four loading doses of
intravitreal ranibizumab, before Susvimo implantation at week 16.
The primary endpoint of the study is a change in best-corrected
visual acuity score (the best distance vision a person can achieve
– including with correction such as glasses – when reading letters
on an eye chart) from baseline at the average of week 60 and week
64. Following primary analyses, participants who were initially
randomised to intravitreal injections received Susvimo, with
refills every 24 weeks.
About the Pavilion
study2
Pavilion (NCT04503551) is a multicentre, randomised, US-based Phase
III study evaluating the efficacy, safety and pharmacokinetics of
Susvimo® (Port Delivery System with ranibizumab) 100 mg/mL refilled
every nine months compared with people under monthly clinical
observation, in 174 people with diabetic retinopathy without
centre-involved diabetic macular edema. Participants were
randomised 5:3 to receive either Susvimo with refills every nine
months or monthly clinical observation, respectively. In the
Susvimo arm, participants received two loading doses of
intravitreal ranibizumab, before Susvimo implantation at week 4.
The primary endpoint was the proportion of participants with at
least a two-step improvement from baseline on the Early Treatment
Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at
week 52. Following the primary analyses, participants initially in
the clinical observation arm received two ranibizumab loading doses
before Susvimo implantation at week 64.
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.5 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.25
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 United States Food and Drug Administration
in 2006.13
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 an innovative cell therapy 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.5,10
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.11,26,27 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.27-32 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.
*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 efficacy, safety
and pharmacokinetics of the Port Delivery System with ranibizumab
in participants with diabetic macular edema (DME) compared with
intravitreal ranibizumab (Pagoda). [Internet; cited July 2024].
Available from: https://clinicaltrials.gov/study/NCT04108156.
[2] Clinical Trials.gov. A multicentre, randomised study in
participants with diabetic retinopathy (DR) without centre-involved
DME to evaluate the efficacy, safety and pharmacokinetics of
ranibizumab delivered via the Port Delivery System with ranibizumab
relative to the comparator arm (Pavilion). [Internet; cited July
2024]. Available from:
https://clinicaltrials.gov/study/NCT04503551.
[3] Tremolada G, Del Turco C, Lattanzio R, et al. The role of
angiogenesis in the development of proliferative DR: impact of
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[4] Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and
major risk factors of DR. Diabetes Care. 2012;35:556-564.
[5] 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.
[6] Khanani AM. Port Delivery System with ranibizumab in patients
with DME: Primary analysis results of the Phase III Pagoda trial.
Presented at: The Bascom Palmer Eye Institute Angiogenesis,
Exudation, and Degeneration Annual Meeting; 2023 Feb 10-11;
virtual.
[7] Pieramici D. Port Delivery System with ranibizumab in patients
with DR: Primary analysis results of the Phase III Pavilion trial.
Presented at: The Bascom Palmer Eye Institute Angiogenesis,
Exudation, and Degeneration Annual Meeting; 2023 Feb 10-11;
virtual.
[8] Awh C, et al. Port Delivery System with ranibizumab for
continuous treatment of DME: First readout of the Phase III Pagoda
trial two-year results. Presented at: The American Society of
Retina Specialists (ASRS) 2024 Annual Meeting; 2024 July 17;
Stockholm, Sweden.
[9] Chang A, et al. Port Delivery System with ranibizumab for
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Retina Specialists (ASRS) 2024 Annual Meeting; 2024 July 17;
Stockholm, Sweden.
[10] United States (US) Food and Drug Administration (FDA).
Highlights of prescribing information, Susvimo. 2021. [Internet;
cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.
[11] 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.
[12] US FDA. Highlights of prescribing information, Eylea. 2011.
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125387s075lbl.pdf.
[13] 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.
[14] Khoramnia R, et al. Exploring the role of retinal fluid as a
biomarker for the management of DME. Eye. 2024;38:54-60.
[15] Fundus photographic risk factors for progression of DR. ETDRS
report number 12. Early treatment DR study research group.
Ophthalmology. 1991;98:823-833.
[16] Klein R, Klein BE, Moss SE. How many steps of progression of
DR are meaningful? The Wisconsin epidemiologic study of DR. Arch
Ophthalmol. 2001;119:547-553.
[17] 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;67(4):1244-1251.
[18] The Lancet. Diabetes: A defining disease of the 21st century.
Lancet. 2023;24;401(10394):2087.
[19] All About Vision. Macula lutea. [Internet; cited July 2024].
Available from:
https://www.allaboutvision.com/resources/macula.
[20] National Eye Institute. DR. [Internet; cited July 2024].
Available from:
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/diabetic-retinopathy.
[21] Liu E, et al. DME: Clinical risk factors and emerging genetic
influences. Clinical and Experimental Optometry.
2017;100:569–76.
[22] Shrestha P and Kaiti R, Shyangbo R. Blindness among patients
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descriptive cross-sectional study. J Nepal Med Assoc.
2022;1;60(254):877-880.
[23] Purves D, Augustine GJ, Fitzpatrick D. Neuroscience. 2nd
edition. Sunderland (MA): Sinauer Associates; 2001.
[24] Wong T and Tan TE. The DR “pandemic” and evolving global
strategies: The 2023 friedenwald lecture. Invest. Ophthalmol. Vis.
Sci. 2023;64(15):47.
[25] 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.
[26] 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.
[27] US FDA. Highlights of prescribing information, Vabysmo. 2023.
[Internet; cited July 2024]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761235s003lbl.pdf.
[28] Roche data on file.
[29] 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.
[30] 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.
[31] 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.
[32] 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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