[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche’s
Vabysmo for the treatment of retinal vein occlusion (RVO)
- RVO is the third indication
for Vabysmo, in addition to neovascular or ‘wet’ age-related
macular degeneration and diabetic macular edema
- Approval is based on two
phase III studies demonstrating early and sustained vision
improvements that were non-inferior to aflibercept
- Vabysmo also demonstrated
rapid and robust drying of retinal fluid
- Additional U.S. label update across indications
includes information on rare post-marketing reports of retinal
vasculitis and/or retinal vascular occlusion; reporting rate
is in line with other broadly
used intravitreal treatments
Basel, 27 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the United States Food and Drug Administration
(U.S. FDA) has approved Vabysmo® (faricimab) for the treatment of
macular edema following retinal vein occlusion (RVO). RVO is the
third indication for Vabysmo, in addition to neovascular or ‘wet’
age-related macular degeneration (nAMD) and diabetic macular edema
(DME).1 Together, the three retinal conditions affect around 70
million people worldwide and are among the leading causes of vision
loss.2-5
“Vabysmo is a new treatment option for RVO that can help people
preserve and improve their vision, with the added benefit of
retinal drying,” said Levi Garraway, M.D., Ph.D., Roche’s Chief
Medical Officer and Head of Global Product Development. “The
efficacy and safety profile of Vabysmo has been well established in
global clinical trials and is reinforced by a growing breadth of
real-world evidence, with hundreds of thousands of people
treated.”
Vabysmo is the first and only bispecific antibody approved for
the eye.1,6 Today’s approval in RVO is based on positive results
from the global phase III BALATON and COMINO studies that
demonstrated monthly treatment with Vabysmo provided early and
sustained improvement in vision in people with branch and central
RVO, meeting the primary endpoint of non-inferior visual acuity
gains at 24 weeks compared to aflibercept. This was further
supported by data showing Vabysmo achieved rapid and robust drying
of retinal fluid. In BALATON and COMINO, Vabysmo was generally well
tolerated and the safety profile was consistent with previous
trials. The most common adverse reaction was conjunctival
haemorrhage (3%). Safety results were consistent across study
arms.7-9
Information has also been added to the Warnings and Precautions
section of the U.S. label based on rare post-marketing cases of
retinal vasculitis and/or retinal vascular occlusion, typically in
the presence of intraocular inflammation. The reported rate of
retinal vasculitis with vascular occlusion is 0.06 per 10,000
injections, in line with real-world reported frequencies of other
broadly used intravitreal treatments for people living with nAMD,
DME and RVO.10-12
To date, Vabysmo is approved in more than 80 countries around
the world for people living with nAMD and DME, with approximately 2
million doses distributed globally.12
About retinal vein occlusion (RVO)RVO is the
second most common cause of vision loss due to retinal vascular
conditions. It affects an estimated 28 million adults globally,
mainly those aged 60 or older, and can lead to severe and sudden
vision loss.2,13 The level of angiopoietin-2 (Ang-2) is elevated in
RVO and it is thought that increased Ang-2 expression drives
disease progression.14,15 RVO typically results in sudden, painless
vision loss in the affected eye because the vein blockage restricts
normal blood flow in the affected retina, resulting in ischaemia,
bleeding, fluid leakage and retinal swelling called macular
edema.13,16,17 Currently, macular edema due to RVO is typically
treated with repeated intravitreal injections of anti-vascular
endothelial growth factor therapies.16 There are two main types of
RVO: branch retinal vein occlusion, which affects more than 23
million people globally and occurs when one of the four smaller
‘branches’ of the main central retinal vein becomes blocked; and
central retinal vein occlusion, which is less common, affecting
more than four million people worldwide, and occurs when the eye’s
central retinal vein becomes blocked.2,17
About the BALATON and COMINO
studies8,9BALATON (NCT04740905) and
COMINO (NCT04740931) are two randomised, multicentre,
double-masked, global phase III studies evaluating the efficacy and
safety of Vabysmo®️ (faricimab) compared to aflibercept. For the
first 20 weeks, patients were randomised 1:1 to receive monthly
injections for six months of either Vabysmo (6.0 mg) or aflibercept
(2.0 mg). From weeks 24 to 72, all patients received Vabysmo (6.0
mg) up to every four months, using a treat-and-extend dosing
regimen.
The BALATON study was conducted in 553 people with branch
retinal vein occlusion. The COMINO study was conducted in 729
people with central retinal or hemiretinal vein occlusion. The
primary endpoint of each study was the change in best-corrected
visual acuity from baseline at 24 weeks. Secondary endpoints (weeks
0-24) included change in central subfield thickness and drying of
retinal fluid, from baseline over time up to week 24. Secondary
endpoints (weeks 24-72) were treatment durability at 68 weeks and
continuation of weeks 0-24 endpoints.
About the Vabysmo® (faricimab) clinical development
programmeRoche has a robust phase III clinical development
programme for Vabysmo. The programme includes AVONELLE-X, an
extension study of TENAYA and LUCERNE, evaluating the long-term
safety and tolerability of Vabysmo in neovascular or ‘wet’
age-related macular degeneration (nAMD), and RHONE-X, an extension
study of YOSEMITE and RHINE, evaluating the long-term safety and
tolerability of Vabysmo in diabetic macular edema (DME).18,19 Roche
has also initiated several phase IV studies, including the ELEVATUM
study of Vabysmo in underrepresented patient populations with DME,
the SALWEEN study of Vabysmo in a subpopulation of nAMD highly
prevalent in Asia, as well as the VOYAGER study, a global
real-world data collection platform.20-22 Roche also supports
several other independent studies to further understand retinal
conditions with a high unmet need.12
About Vabysmo® (faricimab)Vabysmo is the first
bispecific antibody approved for the eye.1,6 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.23,24 Vabysmo is approved in more than 80 countries
around the world, including the United States, 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 the United States for people living with macular
edema following retinal vein occlusion. Review by other regulatory
authorities is ongoing.1,6,12,25,26
About Roche in ophthalmologyRoche 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 for
geographic atrophy and other vision-threatening diseases, including
rare and inherited conditions.
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 Food and Drug Administration-approved
refillable eye implant for neovascular or ‘wet’ age-related macular
degeneration that continuously delivers a customised formulation of
ranibizumab over a period of months.27 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.1,6,23,24 Lucentis®
(ranibizumab injection)^ is the first treatment approved to improve
vision in people with certain retinal conditions.28
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 thirteenth 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] U.S. Food and Drug
Administration (FDA). Highlights of prescribing information,
Vabysmo. 2023. [Internet; cited October 2023]. Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf.[2]
Song P, et al. Global epidemiology of retinal vein occlusion: a
systematic review and meta-analysis of prevalence, incidence, and
risk factors. J Glob Health. 2019;9:010427. Song P, et al. Global
epidemiology of retinal vein occlusion: a systematic review and
meta-analysis of prevalence, incidence, and risk factors. J Glob
Health. 2019;9:010427.[3] Yau JWY, et al. Global prevalence and
major risk factors of diabetic retinopathy. Diabetes Care.
2012;35:556–64.[4] Connolly E, et al. Prevalence of age-related
macular degeneration associated genetic risk factors and 4-year
progression data in the Irish population. Br J Ophthalmol.
2018;102:1691–95.[5] Bright Focus Foundation. Age-Related Macular
Degeneration: Facts & Figures [Internet; cited October 2023].
Available from:
https://www.brightfocus.org/macular/article/age-related-macular-facts-figures.[6]
MHRA approves faricimab through international work-sharing
initiative [Internet; cited October 2023]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.[7]
Tadayoni R, et al. Faricimab in RVO: Results from the BALATON and
COMINO phase 3 studies. Presented at: Angiogenesis, Exudation and
Degeneration 2023, 10-11 February 2023; Florida, United States.[8]
Clinical Trials.gov. A study to evaluate the efficacy and safety of
faricimab in participants with macular edema secondary to branch
retinal vein occlusion (BALATON) [Internet; cited October 2023].
Available from: https://clinicaltrials.gov/ct2/show/NCT04740905.[9]
Clinical Trials.gov. A study to evaluate the efficacy and safety of
faricimab in participants with macular edema secondary to central
retinal or hemiretinal vein occlusion (COMINO) [Internet; cited
October 2023]. Available from:
https://clinicaltrials.gov/ct2/show/NCT04740931.[10] Ma P, et al.
Ocular adverse events associated with anti-VEGF therapy: A
pharmacovigilance study of the FDA adverse event reporting system
(FAERS). Frontiers in Pharmacology. 2022;13:1017889.[11] Food and
Drug Administration. FDA AEs reporting system (FAERS) public
dashboard. [Internet; cited October 2023]. Available from:
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard.
[12] Roche data on file.[13] Moorfields Eye Hospital, United
Kingdom National Health Service Foundation Trust. RVO [Internet;
cited October 2023]. Available
from: https://www.moorfields.nhs.uk/condition/retinal-vein-occlusion.[14]
Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal
and choroidal vascular diseases: a review of preclinical data. Eye.
2021;35:1305-1316.[15] Regula JT, et al. Targeting key angiogenic
pathways with a bispecific CrossMab optimized for neovascular eye
diseases. EMBO Molecular Medicine. 2016;8:1265–88.[16]
Schmidt-Erfurth U, et al. Guidelines for the Management of Retinal
Vein Occlusion by the European Society of Retina Specialists
(EURETINA). Ophthalmologica. 2019;242:123-162.[17] Campochiaro P.
Molecular pathogenesis of retinal and choroidal vascular diseases.
Prog Retin Eye Res. 2015;49:67-81.[18] Clinical Trials.gov. A study
to evaluate the long-term safety and tolerability of Vabysmo in
participants with nAMD (AVONELLE-X) [Internet; cited October 2023].
Available
from: https://clinicaltrials.gov/ct2/show/NCT04777201.[19]
Clinical Trials.gov. A study to evaluate the long-term safety and
tolerability of Vabysmo in participants with DME (Rhone-X)
[Internet; cited October 2023]. Available
from: https://clinicaltrials.gov/ct2/show/NCT04432831.[20]
Clinical Trials.gov. A study to investigate faricimab treatment
response in treatment-naïve, underrepresented patients with DME
(ELEVATUM). [Internet; cited October 2023]. Available
from: https://clinicaltrials.gov/ct2/show/NCT05224102.[21]
APVRS. Design and Rationale of the SALWEEN Trial: A Phase 3b/4
Study of Faricimab, a Dual Angiopoietin-2 and Vascular Endothelial
Growth Factor-A Inhibitor, in Patients With Polypoidal Choroidal
Vasculopathy. [Internet; cited October 2023]. Available
from: https://2022.apvrs.org/abstract/?code=200351.[22]
Clinical Trials.gov. A Real-World Study to Gain Clinical Insights
Into Roche Ophthalmology Products (VOYAGER). [Internet; cited
October 2023]. Available
from: https://clinicaltrials.gov/ct2/show/NCT05476926.[23]
Heier JS, et al. Efficacy, durability, and safety of intravitreal
faricimab up to every 16 weeks for neovascular age-related macular
degeneration (TENAYA and LUCERNE): two randomised, double-masked,
phase 3, non-inferiority trials. The Lancet. 2022; 399:729-740.[24]
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
3 trials. The Lancet. 2022; 399:741-755.[25] Chugai obtains
regulatory approval for Vabysmo, the first bispecific antibody in
ophthalmology, for neovascular age-related macular degeneration and
diabetic macular edema [Internet; cited October 2023]. Available
from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.[26]
European Medicines Agency. Summary of Product Characteristics,
Vabysmo, 2022 [Internet; cited April 2023]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.[27]
U.S. FDA. Highlights of prescribing information, Susvimo. 2006
[Internet; cited October 2023]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf.[28]
U.S. FDA. Highlights of prescribing information, Lucentis. 2006
[Internet; cited October 2023]. Available
from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf.
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