Roche Wins EU Approval for Susvimo in Wet AMD

Basel, Switzerland, September 21, 2026

European Approval Expands Susvimo Access

The European Commission authorization allows Susvimo to be used in adults with nAMD who have achieved stable disease after previously responding to intravitreal treatment with a VEGF inhibitor. The European Medicines Agency records show that the marketing authorization was issued on September 18, 2026, following a positive opinion adopted in July. Susvimo contains the active ingredient ranibizumab, a VEGF inhibitor designed to reduce abnormal blood-vessel growth and vascular leakage associated with nAMD.

The approval is particularly relevant because nAMD is a major cause of vision loss among adults over 60. The disease develops when abnormal blood vessels grow beneath the macula, potentially causing fluid accumulation, bleeding and damage to central vision. Roche estimates that approximately 1.7 million people in the European Union are affected by nAMD. Current anti-VEGF treatment approaches can require repeated injections and frequent healthcare visits, creating an ongoing treatment burden for patients and healthcare providers.

Contivue Enables Continuous Drug Delivery

A central feature of the European approval is the combination of Susvimo with the Contivue refillable implant. The system is designed to provide continuous delivery of ranibizumab directly into the eye following a one-time outpatient surgical implantation procedure. The Contivue platform received a CE mark in 2025 and includes the refillable eye implant together with ancillary devices used to fill, insert, refill and, if necessary, remove the implant.

According to Roche, the delivery system can allow people with nAMD to maintain their vision with as few as two treatments per year. This represents a different treatment approach from conventional repeated intravitreal injections. Roche is also investigating whether additional medicines from its ophthalmology pipeline could potentially be delivered through the Port Delivery Platform, with the longer-term objective of expanding treatment options using the technology.

Phase III Evidence Supports Vision Maintenance

The European authorization is based on evidence from the pivotal Phase III Archway study, supported by the Phase II Ladder study and the long-term Portal extension study. In Archway, patients treated with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections. Longer-term Portal data reported by Roche indicated that vision was maintained for up to seven years among patients followed in the extension study. Roche also reported that approximately 95% of patients receiving two refills per year did not require supplemental anti-VEGF treatment in the long-term data. Susvimo was generally well tolerated over the longer-term follow-up reported by the company. These findings supported Roche’s application for European authorization and provide clinical evidence for the use of continuous ranibizumab delivery in appropriately selected patients with nAMD.

The approval strengthens Roche’s ophthalmology portfolio while providing European clinicians with another option for managing neovascular age-related macular degeneration. By combining an established anti-VEGF medicine with a refillable delivery system, Susvimo and Contivue are designed to address both disease control and the practical burden associated with frequent treatment. The European authorization marks an important regulatory milestone for Roche’s ophthalmology strategy and expands access to a less frequently administered treatment option for eligible patients with wet AMD.

Source: Roche press release