Roche to present extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026

  • New real-world data confirm Vabysmo’s potent retinal drying in nAMD and DME
  • Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden
  • Roche will present more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions

Basel, 30 April 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it will showcase key real-world, product and pipeline data from its ophthalmology portfolio at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held 3rd to 7th of May in Denver, Colorado, USA. The data being presented emphasise Roche’s focus on preserving vision through innovative therapies, including Vabysmo® (faricimab), Susvimo® (Port Delivery Platform with ranibizumab) and the investigational interleukin-6 (IL-6) inhibitor, vamikibart. The data cover five retinal conditions including geographic atrophy (GA), retinal vein occlusion (RVO) and uveitic macular edema (UME) as well as diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD).

“The data we will present at ARVO underscore our commitment to advances in ophthalmology in general and our retinal portfolio in particular,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development. "An important example is real-world data for nAMD and DME showing that Vabysmo dries the retina and improves retinal anatomy in both treatment-naïve and previously treated settings."

Vabysmo real-world drying data
New data from the global VOYAGER study (NCT05476926) demonstrate that six months of treatment with Vabysmo dried the retina and improved retinal anatomy in real-world clinical practice. These findings, which utilised a deep learning algorithm to analyse real-world optical coherence tomography images, showed consistent improvements across both treatment-naive patients and those previously treated with other anti-VEGF therapies.

Further highlights from Roche’s ophthalmology portfolio
Reflecting its mission to address diverse patient needs across ophthalmic conditions, Roche will present important new findings from across its ophthalmology portfolio. This includes data exploring the use of Vabysmo in RVO, reinforcing its real-world effectiveness in this patient population. Additionally, new data for Susvimo will highlight its ability to provide sustained disease control, and early data from the investigational IL-6 inhibitor, vamikibart, will offer insights for its potential role in targeting underlying retinal inflammation.

Overview of key presentations featuring Roche medicines:

TopicAbstract TitlePresentation Details

(all timings are MDT)
VabysmoAnatomical outcomes of faricimab in patients with diabetic macular edema: 6-month real-world imaging from the VOYAGER studyPoster #1964 - 0031
Monday 4 May 2026
3:00-4:45 PM
Long-term effectiveness and safety of faricimab in eyes with nAMD: 2-year results from the UK FARWIDE-nAMD studyPresentation (10 mins)
Tuesday 5 May 2026
1:45-2:00 PM
Automated quantification of retinal fluid volume in patients with DME: analysis of faricimab vs aflibercept in YOSEMITE/RHINEPresentation (10 mins)
Tuesday 5 May 2026

2:00-2:15 PM
Anatomical outcomes of faricimab in patients with neovascular age-related macular degeneration: 6-month real-world imaging from the VOYAGER studyPresentation (10 mins)
Tuesday 5 May 2026
2:30-2:45 PM
Reduction in Subretinal Hyperreflective Material Volume With Faricimab vs Aflibercept 2 mg in Treatment-Naïve nAMD: A TENAYA/LUCERNE Post Hoc AnalysisPresentation (10 mins)
Tuesday 5 May 2026
2:45-3:00 PM
One-year outcomes of faricimab patients with DME from a global, prospective observational study: the VOYAGER studyPresentation (10 mins)
Tuesday 5 May 2026
5:00-5:15 PM
One-year outcomes of faricimab treatment in eyes with nAMD from the global, prospective observational VOYAGER studyPresentation (10 mins)
Thursday 7 May 2026
1:15-1:30 PM
SusvimoPatient preference for the PDS vs intravitreal injections: year 2 results from the phase 3 Pagoda trial in patients with diabetic macular edema (DME)Poster #1979 - 0046
Monday 4 May 2026

3:00-4:45 PM
Retinal fluid, thickness, and leakage in PDS-treated study eyes vs intravitreal injection-treated fellow eyes in bilateral DME in the Pagoda trialPoster #1980 - 0047
Monday 4 May 2026
3:00-4:45 PM
Model-based pharmacokinetic simulations of the Port Delivery Platform with ranibizumab (PDS) under various real-world clinical scenariosPoster #1981 - 0048
Monday 4 May 2026

3:00-4:45 PM
Interim analysis of the Belvedere nAMD study: summary of PDS treatment in eyes with high injection burdenPresentation (10 mins)
Thursday 7 May 2026
3:00-3:15 PM
VamikibartEfficacy and safety of vamikibart in patients with diabetic macular edema: first results from the phase 2 ALLUVIUM trialPresentation (10 mins)
Tuesday 5 May 2026
3:30-3:45 PM
Efficacy and safety of vamikibart in combination with ranibizumab in patients with DME: first results from the phase 2 BARDENAS trialPresentation (10 mins)
Tuesday 5 May 2026
3:45-4:00 PM

About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.1-3 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.3,4 Vabysmo is approved in more than 110 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with nAMD and DME, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following RVO.1,2,5-8 Review by other health authorities is ongoing. 

About Susvimo (Port Delivery Platform with ranibizumab)
Approved in the United States by the Food and Drug Administration (FDA) for nAMD, DME and diabetic retinopathy (DR), Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure.8-10 Susvimo continuously delivers a customised formulation of ranibizumab into the eye over time.8-10 Ranibizumab is a 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.9-11

The customised formulation of ranibizumab delivered by Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis® (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.12 In the EU, the devices are collectively referred to as Contivue, and have received EU certification.13 The drug MAA for nAMD is currently under review by the European Medicines Agency (EMA).13

About vamikibart
Vamikibart is an investigational monoclonal antibody that has been specifically engineered for intravitreal (IVT) administration.14,15 It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME.14,15 In the phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME.14,15 Vamikibart was also well tolerated, with no treatment-related serious adverse events reported.15 Based on the promising phase I DOVETAIL data, Roche initiated the two identical phase III vamikibart studies MEERKAT and SANDCAT. Vamikibart is being investigated in retinal diseases with recognised inflammatory pathways, including in people with UME. Vamikibart has orphan drug designation in the USA and EU.

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 innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and UME.

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] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024. [Internet; cited April 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf.
[2] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited April 2026]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[3] 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.
[4] 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.
[5] European Medicines Agency. Summary of product characteristics, Vabysmo. 2026. [Internet; cited April 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[6] 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 April 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[7] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited April 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[8] Roche data on file.
[9] US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2025. [Internet; cited April 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s006lbl.pdf.
[10] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021.
[11] 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.
[12] US FDA. Highlights of prescribing information, Lucentis. 2024. [Internet; cited April 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125156s128lbl.pdf.
[13] Roche. Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD). 2025. [Internet; cited April 2026]. Available from: https://www.roche.com/media/releases/med-cor-2025-09-04.
[14] Khurana RN, et al. Efficacy and Safety of Vamikibart in Patients With Uveitic Macular Edema: First Report of Phase 3 MEERKAT/SANDCAT Trials. Presented at: the American Academy of Ophthalmology annual meeting (AAO 2025); 2025 October 17; Orlando, Florida, United States.[15] Sharma S, Suhler E, Lin P, et al. A novel intravitreal anti-IL-6 monoclonal antibody for uveitic macular edema (UME): preliminary results from the phase 1 DOVETAIL study. Invest Ophthalmol Vis Sci. 2023;64(8):5100.

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