Roche has secured European Commission approval for Susvimo, a refillable eye implant designed to provide continuous delivery of ranibizumab for people with neovascular age-related macular degeneration (nAMD), a leading cause of vision loss among people over 60.

 

The approval gives patients in Europe an alternative to frequent intravitreal eye injections, with Roche positioning the treatment as a way to reduce the burden of repeated clinic visits while maintaining vision outcomes.

 

“The European Commission approval of Susvimo now provides this continuous delivery option to people in Europe with neovascular age-related macular degeneration,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. 

 

“Many nAMD patients are unable to extend their dosing interval beyond every eight weeks, and 40% discontinue treatment within two years. By offering patients continuous delivery through a refillable implant, Susvimo offers a unique alternative to frequent eye injections that can help maintain vision while significantly reducing the treatment burden.”

 

The treatment is delivered through Roche’s Port Delivery Platform, known as Contivue in the European Union. Roche received a CE mark for Contivue in 2025. The platform consists of a refillable eye implant and four ancillary devices used to initially fill, insert, refill and, if required, remove the implant.

 

The implant is inserted during a one-time outpatient procedure and continuously delivers Roche’s customised formulation of ranibizumab directly into the eye. Roche is also evaluating other molecules that could potentially be used with the platform, with the aim of expanding treatment options in the future.

 

“In clinical practice, we see firsthand how the fear of vision loss is compounded by the burden of frequent clinic visits,” said Frank Holz, Professor and Chairman of the Department of Ophthalmology at the University of Bonn, Germany. “By continuously delivering medicine directly into the eye, Contivue with Susvimo allows patients to maintain their vision with as few as two treatments a year.’’

 

The European approval is based on data from three clinical studies: the pivotal Phase III Archway study, the Phase II Ladder study and the long-term extension study Portal.

 

In Archway, patients treated with Susvimo achieved and maintained vision outcomes comparable to those receiving monthly intravitreal ranibizumab injections. Longer-term data from Portal showed that vision was maintained for up to seven years.

 

Roche said that with two refills per year, approximately 95% of patients treated with Susvimo required no supplemental anti-VEGF treatment. The company also reported that Susvimo was generally well tolerated over the longer term.

 

Neovascular, or “wet,” AMD is an advanced form of age-related macular degeneration that can cause rapid and severe vision loss if untreated. The disease develops when abnormal blood vessels grow beneath the macula, potentially causing swelling, bleeding and fibrosis.

 

Around 20 million people worldwide are living with nAMD, according to Roche, with the number expected to rise as populations age.

 

Current treatment often relies on repeated anti-VEGF injections. Roche says many patients cannot extend their dosing interval beyond eight weeks and that 40% discontinue treatment within two years, underscoring the challenge of maintaining long-term treatment.