The European Commission has approved Roche’s Susvimo (ranibizumab 100 mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD), the pharmaceutical giant announced Monday from its Basel headquarters.
Susvimo is delivered through the Contivue refillable implant—part of Roche’s Port Delivery Platform—making it the first and only continuous-delivery treatment for the condition. The system allows patients to maintain vision with as few as two treatments per year, according to Roche.
nAMD is a leading cause of vision loss in adults over 60 and affects approximately 1.7 million people across the European Union. Worldwide, around 20 million people live with the condition.
The approval rests on data from three clinical studies: the pivotal Phase III Archway trial and two supportive studies, the Phase II Ladder trial and the open-label long-term extension study Portal. Archway results showed that Susvimo maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections. Long-term Portal data demonstrated that vision was preserved for up to seven years. With two refills annually, approximately 95% of patients required no supplemental anti-vascular endothelial growth factor (anti-VEGF) treatment, and the therapy was generally well tolerated over the longer term.
"The European Commission approval of Susvimo now provides this continuous delivery option to people in Europe with neovascular age-related macular degeneration," said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development. He noted that many nAMD patients are unable to extend their dosing interval beyond every eight weeks, and 40% discontinue treatment within two years.
Roche was granted a CE mark for the Port Delivery Platform—known as Contivue in the EU—in 2025. The platform comprises the eye implant and four ancillary devices used to initially fill, insert, refill, and remove the implant if needed. Roche is evaluating other pipeline molecules that could potentially be used with the platform to increase efficacy and durability, with the aim of offering multiple treatment options through Contivue.
The U.S. Food and Drug Administration has already approved the device-drug combination as a single product called Susvimo for nAMD, diabetic macular edema, and diabetic retinopathy. The therapy is also approved for nAMD in Switzerland and Thailand.
Ranibizumab is a VEGF inhibitor designed to bind and inhibit VEGF-A, a protein critical to the formation of new blood vessels and vascular leakage. The customised formulation delivered by Contivue differs from the ranibizumab intravitreal injection marketed as Lucentis, which is approved for nAMD and other retinal disorders. Lucentis was developed by Genentech, a fully owned Roche subsidiary, which retains U.S. commercial rights; Novartis holds exclusive commercial rights outside the United States.
Roche said it is investing across its ophthalmology pipeline, which covers retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions including thyroid eye disease and uveitic macular edema. More than 330 million people worldwide are blind or living with vision loss, the company said.
