The European Commission has approved Roche's Susvimo, a ranibizumab 100 mg/mL solution for injection, for the treatment of neovascular age-related macular degeneration, or nAMD, a leading cause of vision loss in people over 60. Susvimo is delivered continuously into the eye through the Contivue refillable implant, making it the first and only continuous delivery treatment offering an alternative to standard-of-care eye injections, and it helps patients maintain their vision with as few as two treatments per year. The approval rests on three clinical studies in nAMD: the pivotal Phase III Archway trial and two supportive studies, the Phase II Ladder study and the open-label long-term extension study Portal, with Archway data showing vision outcomes equivalent to monthly intravitreal ranibizumab injections and Portal data showing vision maintained for up to seven years. With two refills per year, approximately 95% of patients treated with Susvimo required no supplemental anti-VEGF treatment, and the therapy was generally well tolerated over the longer term. Roche was granted a CE mark for its Port Delivery Platform, known as Contivue in the European Union, in 2025; Contivue with Susvimo is also approved for nAMD in Switzerland and Thailand, while in the United States the devices and medicine are approved by the FDA as a single product called Susvimo for nAMD, diabetic macular edema and diabetic retinopathy. nAMD affects approximately 1.7 million people across the European Union and around 20 million people worldwide.
Roche Holding AGEuropean Commission approves Roche's Susvimo for nAMD, expanding its EU market access
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