Roche Susvimo Wins EU Approval for Neovascular AMD

The European Commission has approved Susvimo (ranibizumab 100 mg/mL) for neovascular age-related macular degeneration (nAMD), an advanced form of age-related macular degeneration that can cause rapid and severe central vision loss. The treatment uses Roche’s Contivue Port Delivery Platform to continuously release a customised formulation of ranibizumab directly into the eye.

The approval addresses a major challenge in nAMD management. Although anti-VEGF therapy can preserve vision, many patients require repeated intravitreal injections and regular clinic visits over long periods. Roche reported that many patients cannot extend treatment beyond eight-week intervals, while 40% discontinue treatment within two years.

Archway Demonstrated Comparable Vision Outcomes

The approval is supported by data from the pivotal Phase III Archway study, the Phase II Ladder study and the long-term Portal extension study.

In Archway, patients receiving Susvimo maintained visual outcomes equivalent to those achieved with monthly intravitreal ranibizumab injections. Susvimo uses scheduled refills rather than repeated intravitreal injections, with the nAMD regimen requiring a refill approximately every six months.

Long-term Portal data showed that vision could be maintained for up to seven years. With two refills per year, approximately 95% of patients treated with Susvimo did not require supplemental anti-VEGF treatment, according to Roche.

Continuous Ranibizumab Delivery Through Contivue

Contivue consists of a refillable ocular implant surgically inserted during a one-time outpatient procedure, together with four ancillary devices used for initial filling, insertion, refilling and removal when required. Roche received a CE mark for the Port Delivery Platform, known as Contivue in the EU, in 2025.

Ranibizumab inhibits vascular endothelial growth factor A (VEGF-A), a key driver of abnormal blood-vessel growth and vascular leakage in nAMD. The customised ranibizumab formulation used with the implant differs from conventional intravitreal ranibizumab injection marketed as Lucentis.

Surgical Risks Require Careful Management

While long-term studies showed that Susvimo was generally well tolerated, the implant and associated procedures carry specific ocular risks. These include endophthalmitis, vitreous hemorrhage, retinal detachment, implant dislocation and conjunctival complications.

The FDA prescribing information states that the Susvimo implant has been associated with an endophthalmitis rate up to three times higher than monthly intravitreal ranibizumab. Vitreous hemorrhage has also been reported, with most cases occurring during the first postoperative month in clinical trials.

These risks make appropriate surgical technique, aseptic management and post-procedure monitoring important components of treatment.

nAMD Remains a Major Cause of Vision Loss

nAMD develops when abnormal blood vessels grow beneath the macula, causing fluid accumulation, bleeding and fibrosis. Without treatment, the disease can lead to substantial loss of central vision.

Approximately 1.7 million people in the European Union are affected by nAMD, while around 20 million people live with the condition worldwide. The burden is expected to increase as populations age.

US Development Provides a Precedent for the Platform

Susvimo was first approved in the US in 2021. Genentech voluntarily recalled the ocular implant, insertion tool and initial fill kit in 2022 after testing showed that some implants did not meet performance standards. The company subsequently updated the implant and refill needle, implemented manufacturing-process improvements and reintroduced Susvimo in 2024 following FDA approval of the component updates.

The current US label has since expanded beyond nAMD to include diabetic macular edema and diabetic retinopathy, with different refill intervals for these indications.

Roche Plans to Extend the Delivery Platform

Roche is evaluating additional molecules that could potentially be delivered through the Contivue platform. The company expects the technology could eventually support multiple ophthalmic treatment options, although these programmes remain under development.

The European approval therefore adds another regulatory market for an implant-based approach that shifts anti-VEGF treatment from frequent intravitreal injections toward continuous intraocular delivery, while its surgical safety requirements remain an important consideration in clinical use.

Reference

European Commission approves Roche’s Susvimo® for the treatment of neovascular age-related macular degeneration (nAMD), Roche, 21 September 2026