Roche’s Susvimo (ranibizumab injection) has moved one step closer to European approval.

 

This is after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended its approval for the treatment of neovascular age-related macular degeneration (nAMD).

 

The recommendation marks a potential milestone for patients who currently require frequent eye injections. A final decision from the European Commission is expected in the coming months.

 

Susvimo is designed to provide continuous drug release into the vitreous through Roche’s Contivue implant, offering a new approach to managing nAMD treatment. The system is intended to reduce the frequency of clinic visits by requiring only two refills per year.

 

"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, 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.”

 

The CHMP recommendation is supported by data from three clinical studies in nAMD: the pivotal Phase III Archway study, the Phase II LADDER study, and the open-label long-term extension study Portal.

 

Results from Archway showed that patients treated with Susvimo achieved and maintained vision outcomes comparable to those receiving monthly intravitreal (IVT) ranibizumab injections. Long-term data from Portal demonstrated that vision outcomes were maintained for up to seven years.

 

The studies also showed that with two refills per year, around 95% of patients receiving Susvimo did not require supplemental or additional anti-vascular endothelial growth factor (anti-VEGF) treatment. Susvimo was generally well tolerated during long-term follow-up.

 

In 2025, Roche received a CE mark for its Port Delivery Platform, known as Contivue in the European Union (EU). The platform includes the eye implant used to deliver Susvimo, along with four ancillary devices required for initial filling, insertion, refilling and removal of the implant, if needed.

 

Roche said Contivue has been specifically engineered for use with Susvimo and is also being evaluated with other molecules in the company’s pipeline. The goal is to expand potential treatment options for patients by improving efficacy and durability through the platform.