Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD)
Roche (OTCQX:RHHBY) has received CE mark approval for Contivue, its Port Delivery Platform containing Susvimo, for treating neovascular age-related macular degeneration (nAMD). The platform consists of an eye implant and four ancillary devices for implant management.
New seven-year data from the LADDER study demonstrates strong efficacy, with patients maintaining stable vision and retinal anatomy. The study showed only a six-letter decline in best-corrected visual acuity over seven years, with 95% durability maintained in patients.
The treatment requires only two refills per year, offering a significant improvement over current monthly intravitreal injections. Susvimo is currently under EMA review and could become the first continuous delivery treatment for nAMD, which affects 1.7 million people in the European Union.
Roche (OTCQX:RHHBY) ha ottenuto il marchio CE per Contivue, la sua piattaforma di somministrazione portabile contenente Susvimo, per il trattamento della degenerazione maculare umida correlata all'et脿 (nAMD). La piattaforma 猫 composta da un impianto oculare e quattro dispositivi ausiliari per la gestione dell'impianto.
I nuovi dati a sette anni dello studio LADDER mostrano un'ottima efficacia, con i pazienti che mantengono una visione e un'anatomia retinica stabili. Lo studio ha rilevato solo un calo di sei lettere nell'acuit脿 visiva corretta per sette anni, con una durabilit脿 mantenuta nel 95% dei pazienti.
Il trattamento richiede solo due ricariche all'anno, offrendo un miglioramento significativo rispetto alle attuali iniezioni intravitreali mensili. Susvimo 猫 attualmente in revisione presso l'EMA e potrebbe diventare il primo trattamento a rilascio continuo per la nAMD, che interessa 1,7 milioni di persone nell'Unione Europea.
Roche (OTCQX:RHHBY) ha obtenido el marcado CE para Contivue, su Plataforma de Entrega Port谩til que contiene Susvimo, para el tratamiento de la degeneraci贸n macular neovascular relacionada con la edad (nAMD). La plataforma consta de un implante ocular y cuatro dispositivos auxiliares para la gesti贸n del implante.
Los nuevos datos a siete a帽os del estudio LADDER demuestran una fuerte eficacia, con pacientes que mantienen la visi贸n y la anatom铆a retiniana estables. El estudio mostr贸 solo una p茅rdida de seis letras en la agudeza visual corregida en siete a帽os, con una durabilidad del 95% mantenida en los pacientes.
El tratamiento requiere solo dos recargas al a帽o, ofreciendo una mejora significativa respecto a las inyecciones intrav铆treas mensuales actuales. Susvimo est谩 actualmente en revisi贸n por la EMA y podr铆a convertirse en el primer tratamiento de liberaci贸n continua para la nAMD, que afecta a 1,7 millones de personas en la Uni贸n Europea.
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LADDER 鞐瓣惮鞚� 靸堧鞖� 7雲� 鞛愲電� 雴掛潃 須姤鞚� 氤挫棳欤茧┌, 頇橃瀽霌れ潃 鞁滊牓瓿� 毵濍 甑“毳� 鞎堨爼鞝侅溂搿� 鞙犾頄堨姷雼堧嫟. 鞐瓣惮鞐愳劀電� 7雲� 霃欖晥 斓滊寑甑愳爼鞁滊牓鞐愳劀 雼 6旮�鞛� 臧愳唽毵� 甏�彀半悩鞐堦碃, 頇橃瀽霌れ潣 95%鞐愳劀 歆�靻嶌劚鞚� 鞙犾霅橃棃鞀惦媹雼�.
鞚� 旃橂電� 鞐瓣皠 雼 霊� 氩堨潣 氤挫订毵� 頃勳殧頃� 旮办〈鞚� 鞗旊硠 鞙犽Μ觳措偞 欤检偓鞐� 牍勴暣 韥� 臧滌劆鞚� 鞝滉车頃╇媹雼�. Susvimo電� 順勳灛 EMA 鞁偓 欷戩澊氅�, 鞙犽熃鞐绊暕鞐愳劀 170毵� 氇�鞐愱矊 鞓來枼鞚� 氙胳箻電� nAMD鞐� 雽�頃� 斓滌磮鞚� 歆�靻嶌爜 鞝勲嫭 旃橂臧� 霅� 靾� 鞛堨姷雼堧嫟.
Roche (OTCQX:RHHBY) a obtenu le marquage CE pour Contivue, sa plateforme d'administration implantable contenant Susvimo, pour le traitement de la d茅g茅n茅rescence maculaire li茅e 脿 l'芒ge n茅ovasculaire (nAMD). La plateforme se compose d'un implant oculaire et de quatre dispositifs auxiliaires pour la gestion de l'implant.
Les nouvelles donn茅es 脿 sept ans de l'茅tude LADDER montrent une forte efficacit茅, les patients conservant une vision et une anatomie r茅tinienne stables. L'茅tude n'a r茅v茅l茅 qu'une perte de six lettres de l'acuit茅 visuelle corrig茅e en sept ans, avec une durabilit茅 maintenue chez 95% des patients.
Le traitement n茅cessite seulement deux recharges par an, offrant une am茅lioration significative par rapport aux injections intravitr茅ennes mensuelles actuelles. Susvimo est actuellement en cours d'examen par l'EMA et pourrait devenir le premier traitement 脿 d茅livrance continue pour la nAMD, qui touche 1,7 million de personnes dans l'Union europ茅enne.
Roche (OTCQX:RHHBY) hat die CE-Kennzeichnung 蹿眉谤 Contivue, seine Port-Delivery-Plattform mit Susvimo, zur Behandlung der neovaskul盲ren altersbedingten Makuladegeneration (nAMD) erhalten. Die Plattform besteht aus einem Augenimplantat und vier Hilfsger盲ten zur Implantatverwaltung.
Neue Sieben-Jahres-Daten aus der LADDER-Studie zeigen eine starke Wirksamkeit: Die Patienten behielten stabile Sehfunktion und Netzhautstruktur. Die Studie verzeichnete 眉ber sieben Jahre lediglich einen R眉ckgang um sechs Buchstaben in der bestkorrigierten Sehsch盲rfe, wobei bei 95% der Patienten eine Dauerwirksamkeit erhalten blieb.
Die Behandlung erfordert nur zwei Nachf眉llungen pro Jahr und stellt damit eine deutliche Verbesserung gegen眉ber den derzeitigen monatlichen intravitrealen Injektionen dar. Susvimo wird derzeit von der EMA gepr眉ft und k枚nnte die erste kontinuierlich abgebende Behandlung 蹿眉谤 nAMD werden, die in der Europ盲ischen Union 1,7 Millionen Menschen betrifft.
- CE mark approval received for Contivue platform, expanding market reach
- Seven-year LADDER study shows strong long-term efficacy with only 6-letter vision decline
- 95% durability maintained in patients over seven years
- Treatment requires only 2 refills per year vs. current monthly injections
- Large market opportunity with 1.7 million nAMD patients in EU
- Susvimo still pending EMA approval for use in the platform
- Six-letter vision decline observed over seven-year period
- Susvimo is under review with the EMA and once approved will be the first continuous delivery treatment for nAMD, affecting 1,7 million in the European Union1
- New seven-year data from the LADDER study show Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term2
- With up to two refills per year, Contivue with Susvimo provides reliable, long-term vision outcomes and is approved in the US for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR)2-5
Basel, 04 September 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the EU CE mark for its Port Delivery Platform containing Susvimo, which will now be known as Contivue庐 in the EU.6 The device comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill, and remove the implant (if required).6 Susvimo庐 (ranibizumab injection) 100 mg/mL is currently under review with the European Medicines Agency (EMA) for the treatment of nAMD.6 With immediate and predictable durability, Contivue with Susvimo provides continuous delivery of a customised formulation of ranibizumab directly to the eye.6
鈥淪usvimo offers people living with nAMD the opportunity to maintain their vision with as few as two treatments per year,鈥� said Levi Garraway, MD, PhD, Roche鈥檚 Chief Medical Officer and Head of Global Product Development. 鈥淢oreover, this sustained delivery brings substantial long-term clinical benefits, as demonstrated by the seven years of follow-up data from the LADDER study.鈥�
Three clinical studies contribute to the EMA鈥檚 evaluation of efficacy and safety of Contivue with Susvimo in nAMD: one pivotal Phase III study, Archway, and two supportive studies, the Phase II LADDER study and the open-label long-term extension study Portal. Data from Archway showed patients treated with Contivue with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections.7
New long-term data from the LADDER study, presented at the 25th EURETINA Congress in Paris, France, shows that Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term.2 In the 59 patients continuously treated with Contivue with Susvimo over seven years, best-corrected visual acuity (BCVA) was 70.4 letters at baseline and 63.2 letters at seven years, an average decline of only six letters approximately over that time for patients who were at or near peak levels at the time of enrolment after receiving three intravitreal injections of standard of care.2 Half of all patients had approximately 20/40 vision at seven years (Snellen visual acuity test). Contivue with Susvimo durability was maintained in approximately
鈥淭he seven-year results from the LADDER study powerfully demonstrate the long-term outcomes delivered by Contivue with Susvimo,鈥� said study investigator Carl C. Awh, MD, FASR, Tennessee Retina, Nashville, TN, USA . 鈥淔or patients with nAMD, the sustained drug delivery of Contivue with Susvimo may provide superior visual outcomes compared to the well-demonstrated average decline in vision associated with long-term intravitreal injections.鈥欌��
The port delivery platform devices have been specifically engineered for use with a customized formulation of ranibizumab that is gradually released over time. Roche has several molecules in the pipeline with potential for use with the port delivery platform for continued growth and expansion.
About neovascular age-related macular degeneration
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or 鈥榳et鈥� AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.8-10 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.10 Worldwide, around 20 million people are living with nAMD 鈥� the leading cause of vision loss in people over the age of 60 鈥� and the condition will affect even more people around the world as the global population ages.8, 11-12
About Contivue with Susvimo (Port Delivery Platform with ranibizumab)
Contivue is a refillable eye implant surgically implanted into the eye during a one-time, outpatient procedure.2-4,13 Contivue also includes four ancillary devices to initially fill, insert, refill, and remove the implant.
Contivue with Susvimo delivers a customised formulation of ranibizumab, Susvimo, over time.5 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.2-4,14 The customised formulation of ranibizumab, Susvimo, delivered by Contivue with Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis庐 (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.15
In the US, the devices (refillable eye implant and ancillary devices) and medicine (customised formulation of ranibizumab) are approved by the Food and Drug Administration (FDA) as a single product, called Susvimo for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR).2-4
About Roche in ophthalmology
Roche is focused on saving people鈥檚 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 conditions. 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 uveitic macular edema.
Applying our extensive experience, we have brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo庐 (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first US FDA-approved refillable eye implant for neovascular or 鈥榳et鈥� age-related macular degeneration (nAMD), DME and DR that continuously delivers a customised formulation of ranibizumab over a period of months.3-4 Vabysmo庐 (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.16 Vabysmo is approved around the world for people living with nAMD, DME and macular edema following retinal vein occlusion.14 Lucentis庐 (ranibizumab injection) was the first treatment approved to improve vision in people with certain retinal conditions.15
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world鈥檚 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.
For over 125 years, sustainability has been an integral part of Roche鈥檚 business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
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All trademarks used or mentioned in this release are protected by law.
References
[1] Li at al. Retinal diseases in Europe.Prevalence, incidence and healthcare needs. 2017 [Internet; cited August 2025]. Available from:听
[2] Khanani et al. First-Time Long-Term Efficacy and Safety Outcomes of PDS Patients Enrolled in the Ladder Phase 2 Trial of PDS for nAMD Followed for up to ~7 Years. 4-7 September, EURETINA 2025.
[3] Roche. FDA approves Roche鈥檚 Susvimo for diabetic retinopathy. 2025. [Internet;cited September 2025]. Available from:
[4] Roche. FDA approves Roche鈥檚 Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness. 2025. [Internet; cited September 2025]. Available from:
[5]: US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2021. [Internet; cited September 2025]. Available from: .
[6]. Roche data on file
[7] Khanani et al. Five Year Outcomes in nAMD Patients Enrolled in the Archway Study and Treated With the PDS. Presented at: The American Society of Retina Specialists (ASRS) 2025 Annual Meeting; 2025 August 01; Long Beach, California, United States.
[8] Facts & figures - macular degeneration. BrightFocus Foundation. May 15, 2025. [Internet; cited September 2025]. Available from: .
[9] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): Associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3(1). doi:10.1186/s40662-016-0063-5.
[10] Little K, Ma JH, Yang N, Chen M, Xu H. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration - the potential sources and molecular cues for their recruitment and activation. eBioMedicine. 2018;38:283-291. doi:10.1016/j.ebiom.2018.11.029.
[11] Wong WL, et al. Global prevalence of age-related macular degeneration (AMD) and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Global Health. 2014;2:106鈥�16.
[12] Connolly E, et al. Prevalence of AMD associated genetic risk factors and four-year progression data in the Irish population. British Journal of Ophthalmology. 2018 Feb;102:1691-95
[13] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021
[14] 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.
[15] US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited September 2025]. Available from:听.听
[16] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024. [Internet; cited September 2025]. Available from:听 .
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FAQ
What is the significance of Roche's CE mark approval for Contivue (OTCQX:RHHBY)?
What are the key findings from the seven-year LADDER study for Roche's Contivue?
How many treatments per year does Roche's Contivue require compared to current nAMD treatments?
How many people in the European Union could benefit from Roche's Contivue treatment?
What is the current regulatory status of Susvimo for Roche's Contivue platform in Europe?
