Roche’s Susvimo Shows Durable Vision Preservation Over Five Years with Twice-Yearly Treatment in Neovascular AMD
Roche has released compelling new long-term data highlighting the extended efficacy, safety, and durability of its innovative eye implant therapy, Susvimo® (ranibizumab injection), for individuals with neovascular age-related macular degeneration (nAMD). The five-year results were derived from the Phase III Portal study, a long-term extension of the pivotal Archway trial, and presented at the American Society of Retina Specialists (ASRS) 2025 Annual Meeting held in Long Beach, California.
The findings offer significant hope for patients with nAMD—a leading cause of vision loss among adults over 60—by demonstrating that Susvimo can sustain visual acuity and disease control with just two treatments per year. This durability marks a substantial advancement in treatment convenience and patient adherence compared to traditional intravitreal anti-VEGF injections that may require monthly administration.
A New Standard for Durability in Retinal Care
According to the data presented, approximately 95% of patients treated with Susvimo every six months in the Portal study did not require supplemental treatment between refills throughout the five-year period. This sustained therapeutic effect reinforces Susvimo’s unique value proposition: continuous drug delivery via a surgically implanted refillable reservoir that eliminates the burden of frequent injections while preserving vision long-term.
“These long-term results reinforce Susvimo’s 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,” said Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “These 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.”
Dr. John Kitchens, a principal investigator in the trial and a retina specialist at Retina Associates of Kentucky, added, “People with nAMD often experience suboptimal outcomes with real-world anti-VEGF treatment, largely due to the frequency of injections. Continuous delivery of treatment with Susvimo may preserve vision in patients with nAMD for longer in real-world clinical use than IVT injections.”
The Portal Study: Five Years of Continuous Monitoring
The Roche Phase III Portal study enrolled 352 patients who had previously participated in the Archway trial. Participants were divided into two cohorts based on their prior treatment in Archway:
- The Susvimo cohort (n = 220) consisted of individuals who originally received the Susvimo implant and continued biannual refills in Portal.
- The IVT-Susvimo cohort (n = 132) included patients who had previously received monthly intravitreal ranibizumab injections during Archway and transitioned to Susvimo with six-month refill intervals in Portal.
These patients were followed prospectively and continuously, making this cohort the largest long-term dataset for patients with nAMD to date. The results affirm the implant’s ability to deliver stable clinical outcomes, with key indicators such as best-corrected visual acuity (BCVA) and central subfield thickness (CST) remaining stable or showing only minimal decline over the five-year period.
In Roche the Susvimo cohort, mean BCVA declined from 74.4 letters at baseline to 67.6 letters at five years. In the IVT-Susvimo group, BCVA declined from 76.3 to 68.6 letters. Importantly, about 50% of patients in both cohorts retained visual acuity equivalent to better than 20/40 Snellen vision after five years—a level sufficient for activities like driving and reading.
Central subfield thickness, a biomarker for retinal swelling and fluid accumulation, remained similarly stable. The Roche average change in CST from baseline was a minimal reduction of 1.0 µm (95% CI: -13.1, 11.1) in the Susvimo group and 10.3 µm (95% CI: -25.7, 5.0) in the IVT-Susvimo group.
These consistent anatomical and visual outcomes underscore the Roche reliability of Susvimo’s sustained delivery mechanism in controlling nAMD disease activity over a multi-year timeframe.
Addressing Real-World Treatment Burden and Gaps
One of the most pressing challenges in nAMD treatment is adherence to the recommended injection schedule. In real-world clinical settings, patients often fail to maintain monthly appointments due to logistical, psychological, or economic barriers. These treatment lapses can lead to suboptimal vision outcomes, increased disease activity, and irreversible retinal damage.
Susvimo was designed to directly address this issue. Rather than relying on frequent intravitreal injections, the Roche therapy utilizes the Port Delivery Platform—a small, refillable implant surgically inserted in the eye during a one-time outpatient procedure. The implant continuously releases a customized formulation of ranibizumab, enabling therapeutic drug levels to be maintained between refills spaced six months apart.
By freeing patients from monthly injection schedules, Susvimo has the potential to transform Roche nAMD management in both specialty practices and high-volume ophthalmology clinics, improving long-term outcomes and easing capacity constraints on providers.
The Archway and Portal Study Designs
The Archway study (NCT03677934) was a pivotal randomized, multicenter, open-label Phase III trial that enrolled 415 patients with nAMD. All participants were considered “responders” to prior anti-VEGF therapy, having received at least three injections in the six months preceding their enrollment, with a median of five anti-VEGF injections before randomization.
Participants were randomized in a 3:2 ratio to either:
- Susvimo treatment every six months (n = 248), or
- Monthly intravitreal injections of ranibizumab 0.5 mg (n = 167)
The primary endpoint was the change in best-corrected visual acuity (BCVA) at the average of weeks 36 and 40. Secondary endpoints included long-term safety, vision outcomes over time, and anatomical markers such as center point thickness.
At week 96, eligible participants from both groups were invited to enroll in the open-label Portal extension study. In this next phase, those who had already received Susvimo continued on the same six-month refill schedule, while those previously on monthly intravitreal injections received the Susvimo implant and initiated the same semi-annual maintenance regimen.
Now five years into this longitudinal investigation, Portal continues to monitor both safety and efficacy outcomes in an ongoing fashion.
Safety Profile and Device Durability
Throughout the five-year follow-up, Susvimo demonstrated a consistent and manageable safety profile. The frequency of device-related complications remained low, and the majority of adverse events were either mild or moderate in severity.
Importantly, the refillable nature of the implant proved durable across the extended treatment period. No widespread implant failures or Roche refilling limitations were observed, validating the platform’s feasibility for long-term disease management.
These outcomes support the hypothesis that continuous intravitreal drug delivery via a surgically implanted device can match or exceed the efficacy of frequent injections while offering distinct benefits in patient adherence and quality of life.
Implications for Ophthalmologists and Healthcare Systems
The growing prevalence of age-related macular degeneration, particularly among aging populations in the United States, Europe, and parts of Asia, underscores the need for efficient, durable, and scalable treatment options.
Susvimo could offer a strategic advantage not only for patients but also for healthcare systems facing increasing demand for retinal services. By reducing the number of injection visits per patient from 12 per year to just two, the Roche implant may significantly alleviate scheduling backlogs, free up provider time, and improve access for underserved populations.
As Susvimo continues to be evaluated in post-marketing and real-world settings, further data will help elucidate its cost-effectiveness, reimbursement dynamics, and potential utility in broader subpopulations, including those with diabetic macular edema (DME) or retinal vein occlusion (RVO).
The five-year data from the Portal extension study positions Susvimo as a landmark innovation in the treatment of neovascular AMD. Its Roche unique delivery method, extended durability, and maintained efficacy over half a decade mark it as a powerful alternative to conventional monthly anti-VEGF injections.
Roche’s continued investment in this platform—and the growing clinical evidence supporting its use—signals a meaningful shift toward sustained-delivery strategies in retinal medicine. As aging populations increasingly strain Roche healthcare systems, the adoption of less burdensome, longer-acting treatments like Susvimo may be essential in preserving vision and quality of life for millions of patients worldwide.
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 ‘wet’ 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 – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.3,6,7
About Susvimo® (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® (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’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.
For over 125 years, sustainability has been an integral part of Roche’s 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.
