Roche Reports Five-Year Data Supporting Long-Term Durability of Susvimo in Neovascular Age-Related Macular Degeneration

Roche has shared new five-year data from the Phase III Portal study, a long-term extension of the Archway clinical trial (NCT03677934) evaluating Susvimo (ranibizumab injection) for the treatment of people with neovascular age-related macular degeneration (nAMD).¹

According to the emerging data, Susvimo’s immediate and predictable durability continued over the course of five years, with approximately 95% of patients receiving treatment every six months requiring no supplemental treatment before each refill.

Susvimo maintains retinal control and treatment interval durability

In a patient population that entered Archway with a vision at or near peak levels following an average of five intravitreal (IVT) injections per standard of care, Susvimo demonstrated consistent, sustained disease control and retinal drying.

Patients who were originally treated with Susvimo in the Archway study continued to receive refills every six months in Portal (Susvimo cohort). Meanwhile, those originally treated with monthly IVT ranibizumab injections in Archway received Susvimo and then refills every six months (IVT-Susvimo cohort).

Visual acuity and anatomical outcomes over five years

More detailed findings from the Portal extension study show:

• In the Susvimo cohort, best-corrected visual acuity (BCVA) declined from 74.4 letters at baseline to 67.6 letters at year five.
• In the IVT-Susvimo cohort, BCVA decreased from 76.3 letters at baseline to 68.6 letters at year five.
• At the five-year mark, 50% of participants maintained better than 20/40 vision based on Snellen testing.
• Central subfield thickness remained largely unchanged, with a 1.0 µm average reduction in the Susvimo cohort and a 10.3 µm reduction in the IVT-Susvimo cohort.

In a press release, study investigator John Kitchens, MD, Retina Associates of Kentucky, said: “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.”

According to Roche, the group of patients that entered Portal from Archway mark the largest cohort with nAMD to be followed prospectively and continuously for five years in a clinical trial.

Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, added: “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. 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.”

Archway data supported Susvimo’s initial FDA approval

In October 2021, Susvimo was approved by the FDA for the treatment of patients with nAMD who had previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. The approval was based on positive results from Archway, which demonstrated that Susvimo achieved and maintained vision improvements equivalent to monthly ranibizumab injections.²

Archway was a Phase III, randomized, multicenter, open-label study evaluating Susvimo refilled every six months versus monthly IVT ranibizumab 0.5 mg in patients with nAMD.

• A total of 415 participants were randomized in a 3:2 ratio to receive Susvimo or monthly ranibizumab injections.
• All participants had previously responded to anti-VEGF therapy, receiving at least three injections within six months before screening and an average of five before randomization.
• The primary endpoint was the change in BCVA from baseline, averaged across weeks 36 and 40.
• Secondary endpoints included safety, change in BCVA over time, and changes in center point thickness.
• Participants who completed Archway through week 96 were eligible for Portal, which is ongoing.

References

1. Roche’s Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD). News release. Roche. July 31, 2025. Accessed August 4, 2025. https://www.roche.com/media/releases/med-cor-2025-08-01

2. FDA approves Roche’s Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD). News release. Roche. October 21, 2021. Accessed August 4, 2025. https://www.roche.com/media/releases/med-cor-2021-10-22b