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Healthcare · Automotive
Fenebrutinib FENtrepid and FENhance 1 & 2 late-breaking data demonstrate a therapeutic effect on chronic active lesions, addressing a primary driver of long-term disability progression in multiple sclerosis (MS)
Fenebrutinib FENhance 1 & 2 Phase III pooled data show a 55% reduction in annualised relapse rate (ARR) vs active comparator
Following European Commission paediatric approval on 15 October, new Ocrevus OPERETTA 2 Phase III data show 90% of children aged 10–17 remained relapse-free over two years
Featured in "Best of MSToronto2026", Enspryng METEOROID Phase III data highlight significant attack reduction and improved functional recovery in MOGAD, an underserved autoimmune disease
Basel, 21 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new Phase III data for investigational fenebrutinib in multiple sclerosis (MS), demonstrating reduced markers of chronic brain inflammation as well as more comprehensive disease control versus active comparators.1-3 These findings, alongside new Ocrevus® (ocrelizumab) and Enspryng® (satralizumab) data, will be featured across more than 40 abstracts at MSToronto2026 (10th ACTRIMS- ECTRIMS Meeting), held 21 to 23 October in Toronto. Highlights include a fenebrutinib late-breaking presentation and an Enspryng presentation in the “Best of MSToronto2026.4
“Addressing long-term disability progression to preserve people’s independence remains a critical challenge in neuroinflammatory diseases, and particularly in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our recent data indicate that fenebrutinib can inhibit disease activity inside and outside the central nervous system, underscoring its potential to transform care for people living with relapsing and primary progressive forms of multiple sclerosis.”
Fenebrutinib targets progressive biology inside the brain
New data from the pivotal trials in RMS (FENhance 1 and 2) and PPMS (FENtrepid) support the potential of fenebrutinib as the first and only high-efficacy oral medicine for both forms of MS.
Reduction of chronic active lesions (Late-breaking oral #O137): In the first prospective demonstration of a therapeutic effect on chronic active lesions in MS Phase III clinical trials, data show fenebrutinib reduced the volume of slowly expanding lesions (SELs) by up to 30% (p<0.001) in RMS (over 96 weeks) and PPMS (over 120 weeks), along with a 62% (p=0.001) reduction in accumulation of paramagnetic rim lesions (PRLs) in RMS, versus active comparators. These findings demonstrate that fenebrutinib directly targets chronic neuroinflammation in the brain, a primary driver of disability progression in MS.1
Comprehensive disease control (Poster #P1434): In the pooled RMS trials, three quarters (75%) of fenebrutinib-treated patients showed no evidence of disease activity (NEDA-3) meaning zero relapses, zero MRI activity and zero worsening disability at nearly two years, a 70% reduction (p<0.001) versus the comparator. These results show fenebrutinib’s potential to suppress disease activity and delay progression.2
Preserving brain volume and function (Oral #O089): Pooled RMS data show fenebrutinib reduced the annualised relapse rate (ARR) by 55% versus the comparator (p<0.001) over 96 weeks. In addition, fenebrutinib reduced annual total brain volume loss by 23% (p<0.001) and 12-week composite confirmed disability progression by 16% (p=0.04). These findings demonstrate fenebrutinib’s potential to control relapses, to slow brain tissue loss caused by neuronal cell death and to preserve function.3
Ocrevus provides consistent benefits across all age groups
New data show that Ocrevus provides significant and consistent efficacy across a broad MS patient population, from children 10 years of age to older adults.
Two-year data and immune function in paediatric MS (3 posters on the Phase III OPERETTA 2 study): 90% of children with relapsing-remitting MS (RRMS) treated with Ocrevus, who were 10-17 years old at trial entry, remained free of relapses over two years (#P1439).5 Ocrevus selectively depleted target B cells with little to no effect on other immune cells (#P1407), while preserving pre-existing immunity to common childhood vaccines in 81–100% of patients (#P1415). The European Commission approved Ocrevus in this indication on 15 October, following FDA approval in May.6,7
Two-year data in patients >55 years old (Poster #P1426 on the Phase IIIb CONSONANCE study): 53% of participants over 55 years old treated with Ocrevus showed no disability progression after two years, similarly to younger participants (55%), showing Ocrevus maintains its effect on progression as people age.8
Switching from other treatments to Ocrevus: Real-world data show progression was the leading reason for patients switching from ofatumumab to Ocrevus (ePoster #EP2733).9 A separate analysis of patients treated with Ocrevus or ofatumumab for one year show Ocrevus was associated with lower MRI lesion activity (Poster #P0305).10
Enspryng reduces risk of attack and is associated with improved recovery
Exploratory analyses of the pivotal METEOROID trial suggest that in addition to significantly lowering the risk of relapse (AAN 2026), Enspryng was associated with improved recovery and reduced disability progression, which is critical to prevent permanent damage to the optic nerves, spinal cord or brain in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). These findings reinforce Enspryng’s potential to become the first FDA-approved treatment for MOGAD, with a decision in the U.S. expected in January 2027.4,11
Relapse recovery (Oral #O035): Patients treated with Enspryng achieved numerically superior recovery at 12 weeks post relapse versus placebo (median change in Expanded Disability Status Scale [EDSS] of -2 vs -0.5). Overall function was stable (median 0) with Enspryng, compared to worsening (median 0.5) with placebo, as measured with the EDSS at the end of the double-blind period or first relapse.4
About fenebrutinib
Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression.
While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme.
About Ocrevus® (ocrelizumab)
Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months.
About Enspryng® (satralizumab)
Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that binds to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signalling.
Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the U.S. and E.U., with a well-established safety profile in over 16,000 patients. Enspryng was also recently approved for the treatment of thyroid eye disease (TED) in the U.S.
Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE).
About Roche in Neurology
Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally.
Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Oh J, et al. Fenebrutinib Shows a Therapeutic Effect on MS Progressive Biology: Outcomes on Paramagnetic Rim Lesions and Slowly Expanding Lesions in the Phase III FENhance I/II and FENtrepid Trials in Relapsing and Primary Progressive Multiple Sclerosis (#O137). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 23 October 2026; Toronto, Canada.
[2] Cerqueira JJFCA, et al. No Evidence of Disease Activity With Fenebrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results From the Phase III FENhance 1 and 2 Trials (#P1434). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada.
[3] Sormani MP, et al. Efficacy of Fenebrutinib Versus Teriflunomide in Relapsing Multiple Sclerosis: Pooled Analysis Results From the FENhance 1 and 2 Studies (#O089). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada.
[4] Marignier R, et al. Severity and Recovery of Relapses in Patients with Relapsing MOGAD Treated with Satralizumab: Results from the Phase 3 METEOROID Study (#O035). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada.
[5] Deiva K, et al. OPERETTA 2: Continued Follow-Up of the Efficacy and Safety Profile of Ocrelizumab in Pediatric Relapsing-Remitting MS (#P1439). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada.
[6] Bar-Or A, et al. Impact of Ocrelizumab vs Fingolimod on Immune Function in Pediatric Patients With MS in the OPERETTA 2 Study (#P1407). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada.
[7] Banwell B, et al. Vaccination and Disease-Modifying Therapies: Impact of Ocrelizumab vs Fingolimod on Preexisting Vaccine Seropositivity and Vaccine-Preventable Infections in Pediatric Patients With MS in OPERETTA 2 (#P1415). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada.
[8] Butzkueven H, et al. Ocrelizumab Maintains Clinical and Safety Outcomes in Older Patients (>55 Years) with Progressive Multiple Sclerosis: 2-Year Results from the CONSONANCE Study (#P1426). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada.
[9] Marriott J, et al. Switching Patients with Multiple Sclerosis from Ofatumumab to Ocrelizumab: A Real-World Study of Canadian Healthcare Professionals (#EP2733). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21-23 October 2026; Toronto, Canada.
[10] Ziemssen T, et al. Brain Volume Loss and T2 Lesion Activity in RRMS: Real-World Longitudinal Comparison of Ocrelizumab vs. Ofatumumab (#P0305). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada.
[11] Levy M, et al. Safety and Efficacy of Satralizumab in Patients with Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD): Results from the Phase 3 METEOROID Trial (PL5.006). Presented at: 78th Annual Meeting of the American Academy of Neurology (AAN) 2026; 21 April 2026; Chicago, IL, USA.
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
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Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
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Irène Stephan
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Roche Investor Relations
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Attachment
Media&Investor Release MSToronto2026 English
Oct 21 · 12:00·Roche
AI · SaaS
Lunit (KRX: 328130), a leading provider of AI for cancer diagnostics and precision oncology, today announced that five studies involving its AI-powered pathology platform, Lunit SCOPE, will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain. -- Five studies to be presented, with key research examining AI-based biomarker assessment and tumor micr
Oct 21 · 10:34·MarketersMEDIA
Automotive · Media
Hyundai Universal Solution project will support STEM education across 13 schools in East and North Jakarta, Indonesia
EV bus-based mobile education project will provide learning opportunities for approximately 1,300 students and 130 teachers
EV-focused educational content includes Minecraft quests, animated videos, learning kits and teacher guidance
Hyundai Motor, the Indonesian Ministry of Primary and Secondary Education (Kemendikdasmen) and Save the Children will collaborate with participating schools to deliver the project
Oct 21 · 07:30·Hyundai Motor Company
Government & policy
Today, the President’s Commission on White House Fellows announced the appointment of 11 exceptional Americans who will serve as White House Fellows for a one-year term. The 2026-2027 Class of White House Fellows represents a cross-section of professions including law enforcement, business, academia, and five branches of the military. The White House Fellows program was […]
The post White House Appoints 2026-2027 Class of White House Fellows appeared first on The White House.
Oct 20 · 21:30·The White House
Finance · Industrial
Investment funds managed by Morgan Stanley Capital Partners (MSCP), the middle market private equity buyout team within Morgan Stanley Investment Management, announced today the acquisition of The Rapid Group (TRG), a leading provider of inspection, repair and maintenance services for rotating equipment across municipal, commercial and industrial end markets. Headquartered in Paterson, New Jersey, TRG serves more tha
Oct 20 · 04:00·Morgan Stanley
Healthcare · Biotech & pharma
In the news release, AbbVie to Present Data at the 2026 European Society for Medical Oncology (ESMO) Congress Highlighting Progress Across its...
Oct 19 · 01:18·AbbVie
Finance · Healthcare
Eli Lilly and Company (NYSE: LLY) today announced that new data from across its oncology portfolio will be presented at the European Society for...
Oct 18 · 22:05·Eli Lilly and Company
Government & policy
GSK will present more than 20 abstracts from its expanding solid tumour portfolio at the 2026 ESMO congress
Oct 16 · 13:49·GSK
Automotive · Industrial
Hyundai Motor Group to invest USD 15.5 billion from 2026 through 2032, positioning India as a core strategic market driving future growth and expansion across emerging markets
Hyundai Motor Group Executive Chair Euisun Chung and Indian Prime Minister Hon’ble Shri Narendra Modi Ji discuss India’s automotive industry future and long-term growth strategy
Hyundai Motor Group’s investment spans manufacturing expansion, R&D infrastructure development, local supplier cultivation and future technology innovation to advance India’s automotive industry ecosystem
Hyundai Motor Group to establish a dedicated investment entity in India for seamless execution and efficient capital management
Investment to strengthen India's automotive sector, enhance global technology competitiveness and bolster the nation as a global export hub
Oct 13 · 13:00·Hyundai Motor Company
Travel · Aerospace & defense
Delta will delay the planned launch of its nonstop service between Atlanta and Riyadh, Saudi Arabia, amid evolving developments in the region. The safety and security of our customers and employees always come first and continue to guide our operational decisions. We remain in close contact with relevant government and aviation partners, including Saudia and Riyadh Air, as we monitor the situation.
Saudi Arabia remains an important market for Delta, and we are committed to serving the Kingdom for the long-term. We look forward to connecting Saudi Arabia to Delta's global network in March 2027.
Customers with affected travel plans can visit the My Trips section of delta.com to review their options, including refunds. A travel waiver for Riyadh is available, and we encourage customers to visit the Delta app or delta.com now to review rebooking options and make changes to their trip. Flexible options, including a refund of the unflown portion of the trip, are available for customers with affected travel.
Oct 12 · 14:00·Delta Air Lines
AI · SaaS
Software-as-a-Service solution arrives on Microsoft Marketplace at a time when AI trust is at a premium SAS® AI Navigator is now available to help AI, data, compliance and risk leaders bring order to AI chaos. The new SaaS AI governance solution, available on Microsoft Marketplace, enables leaders to compile a complete AI inventory and align AI use cases with government regulations and internal policies. Organization
Oct 5 · 04:00·SAS
AI · Healthcare
New real-world results for Vabysmo in nAMD, DME and RVO reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals1-3
Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care4,5
With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide1-3
Basel, 1 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo® (faricimab) in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).1-3 Across all study cohorts, results confirm the real-world effectiveness of Vabysmo in line with Phase III trial results, with vision gains and robust anatomical improvements in untreated eyes and stable or improved vision with improved anatomical outcomes in previously treated eyes.1-3
In the nAMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment.1,2 In RVO, both subtypes of the disease showed improvements in efficacy in people treated with Vabysmo.3 In the central/hemi-RVO cohort, vision and CST improved in both previously untreated and treated eyes after six months of Vabysmo therapy.3 In the branch RVO cohort, vision and CST improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after six months of Vabysmo treatment.3 The data are being presented at the EURETINA 2026 Annual Meeting in Vienna, Austria.
“These real-world results underscore how the efficacy and safety observed in our pivotal Vabysmo studies translate directly into routine clinical practice globally,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The sustained visual improvements and meaningful anatomical drying seen in the VOYAGER study reinforce the role of Vabysmo in helping to address important unmet needs for patients with retinal conditions.”
“In daily clinical practice, we manage diverse patient populations with complex treatment histories who don’t always mirror the strict entry criteria of controlled Phase III trials.” said Professor Robyn Guymer, Chair of the VOYAGER Steering Committee and Deputy Director of the Centre for Eye Research Australia. “The latest VOYAGER data give physicians from across the world the confidence that Vabysmo delivers sustained visual gains, meaningful anatomical drying, and an established safety profile in everyday practice – whether a patient is starting treatment for the first time or transitioning from another therapy.”
The new VOYAGER real-world data in nAMD, DME and RVO are consistent with previous Phase III study results and demonstrate the effectiveness, durability and safety of Vabysmo across diverse global practices.1-3 Across all cohorts of the study, the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) was consistently reduced in previously untreated and treated eyes.1-3 In the nAMD and DME groups, fewer Vabysmo injections were received during months 7-12 compared with months 1-6, suggesting extension of treatment intervals.1,2
Mean change in visual acuity (VA)
Early Treatment Diabetic Retinopathy Study (ETDRS) lettersMean change in central subfield thickness (CST)
µmPresence of subretinal fluid (SRF)
% of eyesPresence of intraretinal fluid (IRF)
% of eyes
nAMD (after 12 months of Vabysmo treatment)1
No prior treatment+4.6–110.572.1→25.348.5→20.6
Previously treated-0.1-26.161.6→37.935.4→25.0
DME (after 12 months of Vabysmo treatment)2
No prior treatment+8.2-127.826.5→6.887.3→58.1
Previously treated+2.7-71.322.1→9.380.5→68.1
Branch RVO (after 6 months of Vabysmo treatment)3
No prior treatment+10.0-171.336.3→11.883.8→50.0
Previously treated+2.0-59.015.9→6.682.6→80.3
Central/hemi-RVO (after 6 months of Vabysmo treatment)3
No prior treatment+16.6-287.450.7→9.885.7→29.4
Previously treated+3.9-63.414.9→10.389.4→74.4
In VOYAGER, the Vabysmo safety profile was generally consistent with that established in the Phase III studies in nAMD, DME and RVO.1-3
About VOYAGER
VOYAGER is the largest global, prospective, non-interventional real-world study of Vabysmo (faricimab).1-3 It captures real-world data from 28 countries/regions across six continents representing more than 5,000 patients treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) or retinal vein occlusion (RVO).1-3 The study leverages state-of-the-art AI and deep learning algorithms to evaluate SD-OCT images captured during routine clinical practice.4-6
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.7-9 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.9,10 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO).7,8,11-14 Review by other health authorities is ongoing.
About Roche in Ophthalmology
At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care.
Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Guymer R, et al. One-year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With nAMD From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[2] Sheth V, et al. One–Year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With DME From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[3] Hattenbach L-O, et al. Real-World Clinical and Anatomical Outcomes With Faricimab in Patients With Retinal Vein Occlusion From a Global, Prospective Observational Study: The VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[4] Bailey C, et al. Anatomical Outcomes of Faricimab in Patients with Neovascular Age-Related Macular Degeneration: 12-Month Real-World Imaging from the VOYAGER Study. Presented at:26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[5] Koh A, et al. Anatomical Outcomes of Faricimab in Patients with Diabetic Macular Edema: 12-Month Real-World Imaging from the VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[6] Guymer R, Bailey C, Chaikitmongkol V, et al. Rationale and Design of VOYAGER: Long-term Outcomes of Faricimab and Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Clinical Practice. Ophthalmol Sci. 2024;4(3):100442. doi:10.1016/j.xops.2023.100442.
[7] United States (US) Food and Drug Administration (FDA). Highlights of Prescribing Information, Vabysmo. April 2026. [Internet; cited September 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761235s008lbl.pdf
[8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. May 17, 2022. [Internet; cited September 2026]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative
[9] Heier JS, Khanani AM, Quezada Ruiz C, 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. Lancet. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1.
[10] Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6.
[11] European Medicines Agency. Summary of Product Characteristics, Vabysmo. August 2026. [Internet; cited September 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[12] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[13] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[14] Roche data on file.
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
Phone: +41 79 961 92 50
Irène Stephan
Phone: +41 79 377 83 75Albert Thottiyil
Phone: +41 79 775 66 12
Attachment
Media Release Vabysmo EURETINA 2026 English
Oct 1 · 06:00·Roche