SHERIDAN, WYOMING -- July 30, 2026 -- Roche Holding AG said the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Susvimo for neovascular age-related macular degeneration, positioning the therapy as the first continuous-delivery alternative to standard eye injections in the European Union. The recommendation covers Susvimo as delivered through Roche's Contivue refillable implant, which the company says can maintain vision with as few as two treatments per year. A final decision from the European Commission is expected in the near term. For ophthalmology practices managing high injection volumes, the recommendation signals a potential shift in how a leading cause of vision loss in patients over 60 is treated across the region.
Positive Opinion Rests on Three Clinical Studies
The CHMP recommendation draws on data from the pivotal phase III Archway study and two supporting studies, the phase II LADDER trial and the long-term extension study Portal. Archway showed that patients treated with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections. Portal's longer-term follow-up data showed vision maintenance extending out to seven years. With two refills annually, roughly 95% of Susvimo-treated patients required no additional anti-VEGF treatment.
Chief Medical Officer Frames the Recommendation Around Visit Burden
Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, tied the recommendation directly to patient treatment burden.
"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," he said. "By requiring only two 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 seven years."
That framing centers the announcement on clinic capacity and patient convenience rather than efficacy alone.
Contivue Platform Builds on 2025 CE Mark
Roche received a CE mark for the Contivue Port Delivery Platform in 2025, covering the eye implant and four ancillary devices used to fill, insert, refill and remove it. The implant is inserted during a one-time outpatient procedure, after which continuous delivery replaces the need for repeated intravitreal injections. Roche said it is evaluating other pipeline molecules for potential use with the same platform, aiming to expand treatment options built around the Contivue delivery mechanism rather than developing each therapy in isolation.
Formulation Differs From Existing Ranibizumab Product
The customized ranibizumab formulation delivered through Contivue is distinct from the standard intravitreal ranibizumab injection marketed as Lucentis, which remains separately approved for nAMD and other retinal conditions. Ranibizumab works by binding to and inhibiting VEGF-A, a protein Roche says plays a central role in abnormal blood vessel formation and vessel leakage in the eye. Susvimo already carries US approval as a combined device-and-medicine product covering nAMD, diabetic macular edema and diabetic retinopathy, and the therapy is also approved in Thailand.
EU Approval Would Address a Sizeable Patient Population
Neovascular AMD affects an estimated 1.7 million people in the European Union and remains a leading cause of blindness in people over 60. Worldwide, Roche estimates around 20 million people live with the condition, a figure the company expects to grow as populations age. A final European Commission decision would extend the treatment option beyond the US and Thailand markets where Susvimo is already available, giving EU retina specialists a continuous-delivery alternative to the injection-based standard of care.