Key Takeaways

  • CHMP has recommended approval of Roche’s Susvimo with the Contivue implant for wet AMD, with a European Commission decision pending
  • Clinical data from the Archway, LADDER, and Portal studies demonstrated vision outcomes comparable to monthly ranibizumab injections, with long-term follow-up supporting maintenance of vision for up to 7 years
  • The Contivue platform is designed to reduce treatment burden through continuous drug delivery requiring only two scheduled refills per year

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Roche’s Susvimo (ranibizumab injection) 100 mg/mL for the treatment of wet age-related macular degeneration (AMD), bringing the therapy one step closer to authorization across the European Union.

The recommendation covers use of Susvimo with the Contivue implant, a refillable ocular implant designed to provide continuous delivery of ranibizumab into the vitreous. A final regulatory decision is expected from the European Commission in the coming months.

"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."

The recommendation follows Roche’s 2025 CE mark for the Port Delivery Platform, marketed in the European Union as Contivue. The platform includes the refillable implant along with ancillary devices used to fill, insert, refill, and, if necessary, remove the implant. The system is specifically engineered for use with Susvimo.

CHMP’s recommendation is supported by data from three clinical studies evaluating the therapy in patients with wet AMD: the phase 3 Archway trial, the phase 2 LADDER study, and the open-label long-term extension study Portal.

According to Roche, results from the pivotal Archway trial demonstrated that patients receiving Susvimo achieved visual outcomes equivalent to those receiving monthly intravitreal ranibizumab injections. Long-term findings from the Portal extension study showed maintenance of visual outcomes for up to 7 years.

Across the studies, approximately 95% of patients treated with Susvimo required no supplemental anti-vascular endothelial growth factor (VEGF) therapy while receiving scheduled refills twice annually. Roche also reported that the treatment was generally well tolerated over extended follow-up.

Roche said Contivue was designed specifically for use with Susvimo but noted that the company is evaluating additional pipeline molecules that could potentially be delivered through the Port Delivery Platform. The goal is to expand future treatment options while potentially improving efficacy or durability.

Outside Europe, Susvimo is approved in the United States for wet AMD, diabetic macular edema (DME), and diabetic retinopathy (DR). In the United States, the refillable implant, ancillary devices, and ranibizumab formulation are regulated as a single product under the Susvimo name. Susvimo is marketed by Genentech in the US. Contivue with Susvimo is also approved for wet AMD in Thailand.