A refillable eye implant that delivers anti-vascular endothelial growth factor (anti-VEGF) therapy continuously — rather than through repeated intravitreal injections — has received European Commission marketing authorization for neovascular age-related macular degeneration (nAMD). The decision clears Roche's (SIX: RO, ROP; OTCQX: RHHBY) Susvimo (ranibizumab 100 mg/mL solution for injection) for use across the EU, where approximately 1.7 million people are affected by the condition — a leading cause of vision loss in adults over 60.
The approval follows a positive CHMP recommendation issued in July 2026 and completes a two-step regulatory process that began when Roche received a CE mark for the Contivue device platform in September 2025. In the EU, the device — known as Contivue — and the medicine, Susvimo, are authorized separately: Contivue is the refillable implant and associated ancillary instruments used to fill, insert, refill, and remove it, while Susvimo is the customized ranibizumab formulation specifically developed for continuous delivery through that system.
The pivotal evidence comes from the Phase III Archway study, in which patients treated with Susvimo via the implant achieved vision outcomes equivalent to monthly intravitreal ranibizumab injections. Longer-term data from the open-label Portal extension study showed vision was maintained for up to seven years, and approximately 95% of patients required no supplemental anti-VEGF treatment with two refills per year. Two supportive studies — the Phase II Ladder study and Portal — contributed to the regulatory package alongside Archway.
Susvimo delivers a customized formulation of ranibizumab, a VEGF-A inhibitor, continuously into the vitreous through the surgically implanted Contivue device. This is mechanistically distinct from standard intravitreal ranibizumab injection (marketed as Lucentis, whose EU commercial rights are held by Novartis), which is administered by repeated intravitreal injection, with treatment intervals determined by the agent and dosing regimen.
The approach reduces injection frequency but does introduce implant- and procedure-related risks, including endophthalmitis, retinal detachment, vitreous hemorrhage, and conjunctival complications described in the US prescribing information.