Roche鈥檚 Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD)
Roche (OTCQX: RHHBY) has announced compelling 5-year data for Susvimo in treating neovascular age-related macular degeneration (nAMD). The Phase III Portal study demonstrated that Susvimo maintained vision with just two refills per year, showing approximately 95% durability in patients requiring no supplemental treatment between refills.
The study tracked 352 patients over five years, with the Susvimo cohort maintaining vision scores from 74.4 letters at baseline to 67.6 letters at 5 years. The IVT-Susvimo cohort showed similar results, from 76.3 to 68.6 letters. Notably, half of all patients maintained better than 20/40 vision at the five-year mark, with stable central subfield thickness measurements.
Susvimo's Port Delivery Platform represents a significant advancement over current treatments that may require monthly eye injections, offering a one-time surgical implant that delivers continuous medication.
Roche (OTCQX: RHHBY) ha annunciato dati convincenti a 5 anni per Susvimo nel trattamento della degenerazione maculare neovascolare legata all'et脿 (nAMD). Lo studio di Fase III Portal ha dimostrato che Susvimo mantiene la vista con appena due ricariche all'anno, evidenziando una durata di circa il 95% nei pazienti che non necessitano di trattamenti supplementari tra una ricarica e l'altra.
Lo studio ha seguito 352 pazienti per cinque anni, con il gruppo Susvimo che ha mantenuto i punteggi visivi da 74,4 lettere all'inizio a 67,6 lettere a 5 anni. Il gruppo IVT-Susvimo ha mostrato risultati simili, passando da 76,3 a 68,6 lettere. 脠 importante sottolineare che la met脿 dei pazienti ha mantenuto una vista migliore di 20/40 dopo cinque anni, con misurazioni stabili dello spessore del campo centrale.
La Port Delivery Platform di Susvimo rappresenta un significativo progresso rispetto ai trattamenti attuali, che spesso richiedono iniezioni oculari mensili, offrendo un impianto chirurgico unico che somministra il farmaco in modo continuo.
Roche (OTCQX: RHHBY) ha anunciado datos convincentes a 5 a帽os para Susvimo en el tratamiento de la degeneraci贸n macular neovascular relacionada con la edad (nAMD). El estudio de fase III Portal demostr贸 que Susvimo mantuvo la visi贸n con solo dos recargas por a帽o, mostrando aproximadamente un 95% de durabilidad en pacientes que no requirieron tratamiento adicional entre recargas.
El estudio sigui贸 a 352 pacientes durante cinco a帽os, con la cohorte de Susvimo manteniendo puntuaciones visuales desde 74.4 letras al inicio hasta 67.6 letras a los 5 a帽os. La cohorte IVT-Susvimo mostr贸 resultados similares, de 76.3 a 68.6 letras. Cabe destacar que la mitad de los pacientes mantuvo una visi贸n mejor a 20/40 al cabo de cinco a帽os, con mediciones estables del grosor del campo central.
La Plataforma de Administraci贸n Port谩til de Susvimo representa un avance significativo sobre los tratamientos actuales que pueden requerir inyecciones oculares mensuales, ofreciendo un implante quir煤rgico 煤nico que proporciona medicaci贸n continua.
搿滌妶(OTCQX: RHHBY)電� 鞁犾儩順堦磤靹� 鞐半牴 甏�霠� 頇╇皹氤�靹�(nAMD) 旃橂毳� 鞙勴暅 Susvimo鞚� 5雲勱皠 臧曤牓頃� 雿办澊韯半ゼ 氚滍憸頄堨姷雼堧嫟. 3靸� 韽劯 鞐瓣惮鞐愳劀電� Susvimo臧� 鞐瓣皠 霊� 氩堨潣 毽晞毵岇溂搿� 鞁滊牓鞚� 鞙犾頃橂┌, 毽晞 靷澊鞐� 於旉皜 旃橂臧� 頃勳殧 鞐嗠姅 頇橃瀽鞐愳劀 鞎� 95%鞚� 歆�靻嶌劚鞚� 氤挫榾鞀惦媹雼�.
鞚� 鞐瓣惮電� 352氇呾潣 頇橃瀽毳� 5雲勱皠 於旍爜 甏�彀绊枅鞙茧┌, Susvimo 攴鸽９鞚� 旮办爛 鞁滌爯 74.4 旮�鞛愳棎靹� 5雲� 頉� 67.6 旮�鞛愲 鞁滊牓 鞝愳垬毳� 鞙犾頄堨姷雼堧嫟. IVT-Susvimo 攴鸽９霃� 鞙犾偓頃� 瓴瓣臣毳� 氤挫棳 76.3 旮�鞛愳棎靹� 68.6 旮�鞛愲 雮橅儉雮姷雼堧嫟. 韸鬼瀳 鞝勳泊 頇橃瀽鞚� 鞝堧皹鞚� 5雲� 鞁滌爯鞐� 20/40 鞚挫儊鞚� 鞁滊牓鞚� 鞙犾頄堨溂氅�, 欷戩嫭 攵�鞙� 霊愱粯 旄§爼霃� 鞎堨爼鞝侅澊鞐堨姷雼堧嫟.
Susvimo鞚� 韽姼 霐滊Μ氩勲Μ 頂岆灚韽检潃 毵れ洈 鞎堦惮 欤检偓臧� 頃勳殧頃� 旮办〈 旃橂氩曥棎 牍勴暣 須嶊赴鞝侅澑 歆勳爠鞙茧, 頃� 氩堨潣 靾橃垹鞝� 鞛勴攲霝�韸鸽 歆�靻嶌爜鞚� 鞎诫 瓿店笁鞚� 鞝滉车頃╇媹雼�.
Roche (OTCQX : RHHBY) a annonc茅 des donn茅es convaincantes sur 5 ans pour Susvimo dans le traitement de la d茅g茅n茅rescence maculaire li茅e 脿 l'芒ge n茅ovasculaire (nAMD). L'茅tude de phase III Portal a d茅montr茅 que Susvimo maintenait la vision avec seulement deux recharges par an, montrant une durabilit茅 d'environ 95% chez les patients ne n茅cessitant aucun traitement suppl茅mentaire entre les recharges.
L'茅tude a suivi 352 patients sur cinq ans, la cohorte Susvimo maintenant des scores visuels passant de 74,4 lettres au d茅part 脿 67,6 lettres 脿 5 ans. La cohorte IVT-Susvimo a montr茅 des r茅sultats similaires, de 76,3 脿 68,6 lettres. Notamment, la moiti茅 des patients conservait une vision meilleure que 20/40 au bout de cinq ans, avec des mesures stables de l'茅paisseur du champ central.
La plateforme Port Delivery de Susvimo repr茅sente une avanc茅e majeure par rapport aux traitements actuels qui peuvent n茅cessiter des injections oculaires mensuelles, offrant un implant chirurgical unique d茅livrant un m茅dicament en continu.
Roche (OTCQX: RHHBY) hat 眉berzeugende 5-Jahres-Daten f眉r Susvimo bei der Behandlung der neovaskul盲ren altersbedingten Makuladegeneration (nAMD) ver枚ffentlicht. Die Phase-III-Portal-Studie zeigte, dass Susvimo die Sehkraft mit nur zwei Nachf眉llungen pro Jahr aufrechterhielt und dabei eine Haltbarkeit von etwa 95% bei Patienten erreichte, die zwischen den Nachf眉llungen keine zus盲tzliche Behandlung ben枚tigten.
Die Studie verfolgte 352 Patienten 眉ber f眉nf Jahre, wobei die Susvimo-Gruppe die Sehsch盲rfe von 74,4 Buchstaben zu Studienbeginn auf 67,6 Buchstaben nach 5 Jahren hielt. Die IVT-Susvimo-Gruppe zeigte 盲hnliche Ergebnisse von 76,3 auf 68,6 Buchstaben. Bemerkenswert ist, dass die H盲lfte aller Patienten nach f眉nf Jahren eine Sehsch盲rfe besser als 20/40 behielt, mit stabilen Messwerten der zentralen Subfelddicke.
Die Port Delivery Platform von Susvimo stellt einen bedeutenden Fortschritt gegen眉ber aktuellen Behandlungen dar, die monatliche Augeninjektionen erfordern k枚nnen, und bietet ein einmaliges chirurgisches Implantat, das kontinuierlich Medikamente abgibt.
- 95% of patients maintained treatment durability over 5 years with just two refills annually
- 50% of patients maintained better than 20/40 vision after 5 years
- Stable central subfield thickness demonstrated consistent disease control
- Reduced treatment burden compared to monthly injections
- Largest prospective 5-year study cohort for nAMD treatment
- Slight decline in vision scores over 5 years (approximately 7-8 letters)
- Requires surgical procedure for initial implant placement
- Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in nAMD, the leading cause of vision loss in people over the age of 60
- With two refills per year, Susvimo maintained vision and stabilised the retina for five years, with durability maintained in approximately
95% of patients - Susvimo was well tolerated over five years and has a well-characterised safety profile
Basel, 01 August 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new, five-year efficacy, safety and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study, of Susvimo庐 (ranibizumab injection) for the treatment of people with nAMD.1 Results show that Susvimo鈥檚 immediate and predictable durability was sustained over five years, with approximately
鈥淭hese long-term results reinforce Susvimo鈥檚 ability to maintain vision and retinal drying over a long period of time for people with nAMD, the leading cause of vision loss in people over age 60,鈥� said Levi Garraway, MD, PhD, Roche鈥檚 chief medical officer and head of Global Product Development. 鈥淭hese robust data reinforce our confidence in Susvimo's unique therapeutic approach, providing an effective alternative to regular eye injections while preserving vision in a sustained manner.鈥�
鈥淧eople with nAMD often experience suboptimal outcomes with real-world anti-VEGF treatment, largely due to the frequency of injections,鈥� said study investigator John Kitchens, M.D., Retina Associates of Kentucky, who presented the data at ASRS. 鈥淐ontinuous delivery of treatment with Susvimo may preserve vision in patients with nAMD for longer in real-world clinical use than IVT injections.鈥�
In the Portal study (n = 352), people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort; n = 220), while those originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received Susvimo and then refills every six months (IVT-Susvimo cohort; n = 132).
Five-year results showed consistent and sustained disease control and retinal drying in a population who entered Archway with vision at or near peak levels after receiving an average of five intravitreal injections per standard of care. In the Susvimo cohort, best-corrected visual acuity (BCVA) was 74.4 letters at baseline and 67.6 letters at 5 years. In the IVT-Susvimo cohort, BCVA was 76.3 letters at baseline and 68.6 at 5 years. Half of all patients had better than 20/40 vision at five years (Snellen visual acuity test). Average central subfield thickness (CST) remained stable, with a 1.0 (
The cohort of people who entered the Portal study from Archway is the largest cohort of people with nAMD to be followed prospectively and continuously for five years in a clinical study.1
Susvimo provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require eye injections as often as once per month. The Port Delivery Platform is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye, addressing certain retinal conditions that can cause vision loss.
About the Archway study and its open-label extension study (Portal)1,2
Archway (NCT03677934) was a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Susvimo refilled every six months at fixed intervals, compared to monthly IVT ranibizumab 0.5 mg in 415 people living with nAMD. Patients were randomized 3:2 to Susvimo (n = 248) or IVT ranibizumab injections (n = 167). Patients enrolled in Archway were responders to prior treatment with anti-VEGF therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit, with an average of five anti-VEGF injections before randomization. The primary endpoint of the study was the change in BCVA score from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in centre point thickness over time. Patients who completed the study at week 96 were eligible to enter the Portal open-label extension study. In Portal, people originally treated with Susvimo in Archway continued to receive Susvimo refills every six months (Susvimo cohort), while those originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received the Susvimo implant and then refills every six months (IVT-Susvimo cohort). Portal is ongoing.
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.3 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.4,5 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.5 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.3,6,7
About Susvimo庐 (Port Delivery System with ranibizumab)
Approved in the United States by the Food and Drug Administration (FDA) for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR), Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure.8,9 Susvimo continuously delivers a customised formulation of ranibizumab over time.8,9 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.8-10
The customised formulation of ranibizumab delivered by 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.11
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.
For more information, please visit .
All trademarks used or mentioned in this release are protected by law.
*Lucentis庐 (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.
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References
[1] Kitchens J, 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.
[2] Regillo C, et al. Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results. Ophthalmology. 2023;130(7):735-747.
[3] Bright Focus Foundation. Age-related macular degeneration (AMD): facts & figures. [Internet; cited July 2025]. Available from:
[4] Pennington KL, et al. Epidemiology of AMD: associations with cardiovascular disease phenotypes and lipid factors. Eye and Vision. 2016;3:34.
[5] Little K, et al. Myofibroblasts in macular fibrosis secondary to nAMD - the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-91.
[6] 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.
[7] Wong WL, et al. Global prevalence of AMD and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. The Lancet Global Health. 2014 Feb;2:106-16.
[8] US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2021. [Internet; cited July 2025]. Available from:
[9] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021.
[10] 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.
[11] US FDA. Highlights of prescribing information, Lucentis. 2012. [Internet; cited April 2025]. Available from:
[12] US FDA. Highlights of prescribing information, Vabysmo. 2024. [Internet; cited April 2025]. Available from:
[13] European Medicines Agency. Summary of product characteristics, Vabysmo. [Internet; cited April 2025]. Available from:
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FAQ
What are the 5-year results for Roche's Susvimo (RHHBY) in treating nAMD?
How often do patients need Susvimo refills compared to traditional nAMD treatments?
What is the durability rate of Roche's Susvimo treatment for nAMD?
How many patients were included in Roche's Susvimo Portal study?
What is the Port Delivery Platform used in Roche's Susvimo treatment?
