CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD)

• Susvimo is the first and only continuous delivery treatment that offers an alternative to standard of care eye injections for nAMD
• Positive recommendation is based on data from the LADDER, Archway and Portal studies showing Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections^1-3
• By continuously delivering medicine into the eye through the Contivue^® refillable implant, Susvimo may help people with nAMD maintain their vision with as few as two treatments per year^1-3
• nAMD is a leading cause of blindness in people over the age of 60 and affects 1.7 million in the European Union (EU)⁴

Basel, 24 July 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Susvimo^® (ranibizumab injection) 100 mg/mL for the treatment of neovascular age-related macular degeneration (nAMD).⁵ Susvimo is intended for continuous release into the vitreous using the Contivue implant.⁶ A final decision is expected from the European Commission in the near future.

“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,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”

In 2025, Roche was granted a CE mark for its Port Delivery Platform, known as Contivue in the European Union (EU), which comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill and remove the implant (if required). Contivue provides continuous delivery of Susvimo directly to the eye.⁶

The positive recommendation is based on data from three clinical studies in nAMD: one pivotal Phase III study, Archway, and two supportive studies, the Phase II LADDER study and the open-label long-term extension study Portal.^1-3 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 seven years.^2,3 With two refills per year, approximately 95% of patients treated with Susvimo required no supplemental/additional anti-vascular endothelial growth factor (anti-VEGF) treatment.³ Susvimo was generally well tolerated over the longer term.^1-3

Contivue has been specifically engineered for use with Susvimo.⁶ Roche is evaluating other molecules in the pipeline that could potentially be used with the Port Delivery Platform to increase efficacy and/or durability, with the future aim of providing multiple treatment options to patients using Contivue.