Home Roche Announces Phase 3 Portal Study Data Showing Susvimo Maintains Efficacy in Wet AMD with Only Two Treatments Per Year for 95% of Patients

Roche Announces Phase 3 Portal Study Data Showing Susvimo Maintains Efficacy in Wet AMD with Only Two Treatments Per Year for 95% of Patients

Aug 02, 2025 07:30 CST Updated 07:30
Roche

Oncology Drug Research, Development, and Manufacturing

Roche announced the latest data from the Phase 3 Portal study of Susvimo (ranibizumab) for the treatment of wet age-related macular degeneration (wet AMD). This study is the long-term extension trial of the Archway Phase 3 clinical study. The analysis shows,Susvimo can provide stable efficacy for up to 5 years. Approximately 95% of patients only need to receive treatment every six months, without requiring additional supplementary treatments.


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In the Portal study (n=352), patients who previously received Susvimo in the Archway study continued to receive Susvimo every six months (n=220), while those who previously received monthly intravitreal injections (IVT) of Lucentis (ranibizumab) in the Archway study switched to Susvimo treatment and subsequently underwent refill every six months (IVT-Susvimo cohort, n=132).


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Five-year study results show that in the Archway study, patients who received an average of five standard intravitreal injections and entered the study with vision at or near its peak, Susvimo continuously achieved disease control and retinal drying. In the Susvimo cohort, best-corrected visual acuity (BCVA) decreased 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, approximately half of the total patients had vision better than 20/40 (Snellen chart test).The average central retinal thickness (CST) of patients remained stable, with a reduction of 1.0 µm (95% CI: -13.1, 11.1) from baseline in the Susvimo cohort and a reduction of 10.3 µm (95% CI: -25.7, 5.0) in the IVT-Susvimo cohort.


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▲Susvimo Eye Injection Diagram (Image Source: Reference [2])


Susvimo is a ranibizumab monoclonal antibody drug delivery system, a refillable ocular implant that can be implanted in the eye through a one-time outpatient surgery.Susvimo Provides Continuous Ranibizumab Infusion for Patients. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a key role in new blood vessel formation and vascular leakage.



References:

[1] Roche’s Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD). Retrieved August 1, 2025 from https://www.globenewswire.com/news-release/2025/08/01/3126063/0/en/Roche-s-Susvimo-maintains-vision-over-five-years-with-two-refills-per-year-in-people-with-neovascular-age-related-macular-degeneration-nAMD.html

[2] Prescribing Information- Susvimo. Retrieved July 18, 2024 from https://www.gene.com/download/pdf/susvimo_prescribing.pdf


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