CHMP recommends approval of Roche’s ranibizumab injection, 100 mg/mL (Susvimo), for treatment of nAMD

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Roche’s ranibizumab injection, 100 mg/mL (Susvimo), for the treatment of neovascular age-related macular degeneration (nAMD).

Susvimo works in conjunction with the company’s port delivery platform, Contivue, which was specifically engineered for use with Susvimo. The device includes a refillable implant surgically inserted into the eye during a one-time, outpatient procedure, and includes 4 ancillary devices to initially fill, insert, refill, and remove the implant. Contivue with Susvimo delivers a customised formulation of ranibizumab over time. 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.

In September 2025, the European Union granted the EU CE mark to Contivue. The EMA’s evaluation of the safety and efficacy of Contivue with Susvimo in AMD was due to 3 clinical studies: 1 pivotal phase 3 study, Archway (NCT03677934); and 2 supportive studies, the phase 2 LADDER study (NCT02510794) and the open-label long-term extension study, Portal (NCT03683251). The CHMP opinion was based on the same results. Data from Archway showed patients treated with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections, with longer-term data in Portal showing maintenance of vision up to 7 years.

More Portal data showed Susvimo’s “immediate and predictable durability was sustained over 5 years, with approximately 95% of people receiving treatment every 6 months requiring no supplemental treatment before each refill.” While enrolled in the Portal study (n=352), patients originally treated with Susvimo in Archway continued to receive Susvimo refills every 6 months (Susvimo cohort; n=220), while the others originally treated with monthly intravitreal (IVT) ranibizumab injections in Archway received Susvimo and then refills every 6 months (IVT-Susvimo cohort; n=123).

The 5-year results demonstrated 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 5 intravitreal injections per standard of care. The Susvimo cohort's best-corrected visual acuity (BCVA) was 74.4 letters at baseline and 67.6 letters at 5 years. Comparatively, the IVT-Susvimo cohort BCVA was 76.3 letters at baseline and 68.6 at 54 years. Using the Snellen visual acuity test, half of all patients had better than 20/40 vision at 5 years. Average central subfield thickness (CST) remained stable in the Susvimo cohorts, with a 1.0 (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.¹

Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, commented on the CHMP opinion, stating, “The positive CHMP recommendation for Susvimo brings us closer to offering a new treatment option for people in Europe who currently face the burden of frequent eye injections. By requiring only 2 refills per year, Contivue with Susvimo offers a continuous drug delivery approach intended to reduce the frequency of clinic visits, with data from clinical trials supporting maintenance of vision up to 7 years.”

The US Food and Drug Administration (FDA) approved Susvimo for the treatment of diabetic retinopathy (DR) in May 2025; Susvimo was first approved by the FDA for the treatment of wet AMD in 2021 and DME in early 2025.

References:

1. CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD). Published July 23, 2026. Accessed July 28, 2026. https://www.roche.com/investors/updates/inv-update-2026-07-24

2. Filkins K. Contivue port delivery platform for nAMD receives CE mark. Published September 4, 2025. Accessed July 28, 2026. https://www.ophthalmologytimes.com/view/contivue-port-delivery-platform-for-namd-receives-ce-mark

3. Harp MD. Kaiser Maharjan E. Genentech’s Susvimo receives new FDA indication for diabetic retinopathy. Published May 22, 2025. Accessed July 28, 2026. https://www.ophthalmologytimes.com/view/genentech-s-susvimo-receives-new-fda-indication-for-diabetic-retinopathy

4. Harp M. FDA approves continuous delivery ranibizumab injection (Susvimo) for the treatment of diabetic macular edema. Published February 4, 2025. Accessed July 28, 2026. https://www.modernretina.com/view/fda-approves-continuous-delivery-ranibizumab-injection-susvimo-for-the-treatment-of-diabetic-macular-edema