Key Takeaways

  • The European Commission has approved Susvimo for wet AMD, providing continuous ranibizumab delivery through Roche’s refillable Contivue ocular implant
  • Clinical data showed vision outcomes comparable with monthly intravitreal ranibizumab, while approximately 95% of patients receiving twice-yearly refills required no supplemental anti-VEGF treatment
  • Roche is evaluating additional molecules for delivery through the Port Delivery Platform, potentially broadening the platform’s future applications in retinal disease

The European Commission has approved Roche’s Susvimo (ranibizumab 100 mg/mL solution for injection) for the treatment of wet age-related macular degeneration (AMD), providing a continuous-delivery alternative to repeated intravitreal anti-VEGF injections for patients in the European Union.

Susvimo is administered through Roche’s Port Delivery Platform, marketed as Contivue in the European Union. The refillable ocular implant is designed to continuously deliver a customized formulation of ranibizumab directly into the eye, with refills performed about twice per year.

“Many nAMD patients are unable to extend their dosing interval beyond every 8 weeks, and 40% discontinue treatment within 2 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," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.

Roche received CE marking for Contivue in 2025. The platform consists of a refillable implant surgically placed in the eye during a one-time outpatient procedure as well as 4 ancillary devices used to initially fill, insert, refill, and, if necessary, remove the implant. Susvimo was specifically developed for administration through the platform. Roche is also evaluating other pipeline molecules that could potentially be delivered through Contivue, with the goal of increasing efficacy and/or durability and potentially expanding the range of treatment options available through the platform.

The European Commission approval was supported by results from 3 clinical studies in wet AMD: the pivotal phase 3 Archway study, the phase 2 Ladder study, and the open-label Portal long-term extension study.

According to Roche, Archway demonstrated that patients treated with Susvimo achieved and maintained vision outcomes equivalent to those receiving monthly intravitreal ranibizumab injections. Longer-term findings from Portal showed that vision outcomes were maintained for up to 7 years.

With twice-yearly refills, approximately 95% of patients receiving Susvimo did not require supplemental anti-VEGF treatment, according to the company. Roche also reported that the treatment was generally well tolerated during longer-term follow-up.

In the United States, the refillable implant, ancillary devices, and customized ranibizumab formulation are approved by the FDA as a single product under the Susvimo name. The product is approved in the United States for wet AMD, diabetic macular edema, and diabetic retinopathy.