Roche’s Susvimo recommended by CHMP for nAMD

Regulatory update

The European Medicines Agency’s CHMP has recommended approval of Susvimo (ranibizumab 100 mg/mL) for treatment of neovascular age‑related macular degeneration; a final decision by the European Commission is expected in the near term.

Clinical evidence

The CHMP opinion is based on data from the pivotal Phase III Archway trial and supportive LADDER (Phase II) and open‑label Portal long‑term extension studies. Trial results showed Susvimo delivered via the implant maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections, with Portal reporting maintenance of vision up to seven years. With two refills per year, approximately 95% of patients did not require supplemental anti‑VEGF treatment; overall tolerability was reported as acceptable over the longer term.

Device and regulatory status

Susvimo is supplied in a customised ranibizumab formulation and is intended for continuous intraocular delivery through the Contivue refillable implant, which is inserted in a one‑time outpatient procedure and serviced with ancillary devices for filling, insertion, refilling and removal. Contivue received a CE mark in 2025. In the US the implant plus medicine are approved as a single product for nAMD and for diabetic macular edema and diabetic retinopathy.

Pipeline and market context

Roche is evaluating other molecules for use with the Port Delivery Platform to extend efficacy or durability. Neovascular AMD is a leading cause of vision loss in people over 60 and affects millions in Europe, creating substantial demand for longer‑acting delivery options.