The immediate and predictable durability of Genentech’s Susvimo’s for the treatment of patients with neovascular age-related macular degeneration (nAMD) was sustained over five years, according to new five-year efficacy, safety, and durability data from the Phase III Portal study, a long-term extension of the Phase III Archway study.
Susvimo provides continuous delivery of a customised formulation of ranibizumab via the Port Delivery Platform – a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure, which introduces medicine directly into the eye.
These long-term results reinforce Susvimo’s ability to maintain vision and retinal drying over a long period of time for people with wet AMD
Results show that approximately 95% of people receiving the therapy every six months required no supplemental treatment before each refill. The data were presented at the American Society of Retina Specialists (ASRS) 2025 Annual Meeting in Long Beach, California.
“These long-term results reinforce Susvimo’s ability to maintain vision and retinal drying over a long period of time for people with wet AMD, the leading cause of vision loss in people over age 60,” said Dr Levi Garraway, chief medical officer and head of Global Product Development at Genentech. “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.”
“People with wet AMD often experience suboptimal outcomes with real-world anti-VEGF treatment, largely due to the frequency of injections,” said study investigator John Kitchens, M.D., Retina Associates of Kentucky, who presented the data at ASRS. “Continuous delivery of treatment with Susvimo may preserve vision in patients with wet AMD for longer in real-world clinical use than IVT injections.”
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 five years. In the IVT-Susvimo cohort, BCVA was 76.3 letters at baseline and 68.6 at five 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 1.4 (95% CI: -13.1, 11.1) µm reduction from baseline in the Susvimo cohort, and a 4.2(95% CI: -25.7, 5.0) µm reduction in the IVT-Susvimo cohort.
The cohort of people who entered the Portal study from Archway is the largest cohort of people with wet AMD to be followed prospectively and continuously for five years in a clinical study.
About Archway
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 wet AMD. Patients were randomized 3:2 to Susvimo (n = 248) or intravitreal (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 randomisation. 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 center 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 IVT ranibizumab injections in Archway received the Susvimo implant and then refills every six months (IVT-Susvimo cohort). Portal is ongoing.
