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Roche’s Susvimo® (Ranibizumab) Approved in EU

Sep 21, 2026

On 21 September 2026, Roche announced that the European Commission (EC) has approved Susvimo® (ranibizumab) as a 100 mg/mL solution for injection for the treatment of neovascular age-related macular degeneration (nAMD).

The European approval follows the CHMP’s positive opinion for Susvimo® in July 2026.  Susvimo® is delivered via an ocular implant, marketed as Contivue® in the EU, for continuous release into the vitreous of the eye.  The Contivue® devices include a refillable implant surgically inserted into the eye during a one-time, outpatient procedure.  Contivue® also includes four ancillary devices to initially fill, insert, refill, and remove the implant

Susvimo® was approved in the US for nAMD in July 2024, diabetic macular oedema in February 2025 and diabetic retinopathy in May 2025.  In the US, the devices and medicine (ranibizumab) are approved as a single product.

The US approvals followed an update and relaunch of the product, after Roche conducted a voluntary recall of the initial version (FDA approved in October 2021) as a result of test results showing some implants did not perform to Roche’s standards.