Roche: European Commission approves Susvimo for nAMD

Regulatory approval

The European Commission has approved Susvimo (ranibizumab 100 mg/mL solution for injection) for the treatment of neovascular age‑related macular degeneration (nAMD).

Clinical evidence

The approval is supported by one pivotal Phase III trial (Archway) and two supportive studies (Phase II Ladder and the open‑label Portal extension). Archway demonstrated that Susvimo maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections, while Portal reported vision maintenance for up to seven years. With two refills per year, approximately 95% of patients did not require supplemental anti‑VEGF treatment.

Delivery platform and dosing

Susvimo is delivered via the Contivue Port Delivery Platform: a surgically inserted, refillable implant plus four ancillary devices to fill, insert, refill and remove the implant. The implant is placed in a one‑time outpatient procedure and provides continuous delivery of a customised ranibizumab formulation, allowing some patients to maintain vision with as few as two treatments a year. The Susvimo formulation differs from the intravitreal ranibizumab injection marketed as Lucentis.

Regulatory context and prevalence

Contivue received a CE mark in 2025. In the US the combined device and medicine are approved by the FDA (as Susvimo) for nAMD, diabetic macular edema and diabetic retinopathy; Contivue with Susvimo is also approved in Switzerland and Thailand. nAMD affects an estimated 1.7 million people in the EU and around 20 million people worldwide.