Roche Gets Nod from European Commission for Susvimo
The European Commission has approved the ranibizumab 100 mg/mL injectable solution (Susvimo) from Roche as a treatment of neovascular age-related macular degeneration.
Swiss healthcare company, Roche, has announced that the European Commission has approved its injectable solution (ranibizumab 100 mg/mL; Susvimo) for the treatment of neovascular age-related macular degeneration (nAMD) (1). The therapy has been developed specifically for use with the company’s refillable implant (Contivue), meaning that patients now have a continuous delivery option as an alternative to standard-of-care eye injections.
“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, in a company press release (1). “Many nAMD patients are unable to extend their dosing interval beyond every eight weeks, and 40% discontinue treatment within two years. By offering patients continuous delivery through a refillable implant, Susvimo offers a unique alternative to frequent eye injections that can help maintain vision while significantly reducing the treatment burden.”
Roche was granted a CE mark within the European Union in 2025 for its refillable implant (2). The company is now evaluating other molecules in its pipeline that could be used with the platform to increase efficacy and/or durability, with the future aim of offering more continuous treatment options.
“In clinical practice, we see firsthand how the fear of vision loss is compounded by the burden of frequent clinic visits,” added Frank Holz, Professor and Chairman of the Department of Ophthalmology at the University of Bonn, Germany, in the company press release (1). “By continuously delivering medicine directly into the eye, Contivue with Susvimo allows patients to maintain their vision with as few as two treatments a year.”
The regulatory approval has been based on data from three clinical studies, comprising one Phase III trial (Archway) and two supporting Phase II trials (Ladder study and the long-term extension study Portal). The Phase III study data demonstrated that patients treated with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections, with longer-term data in the extension study showing that vision was maintained from up to seven years (1).
This decision from the European Commission was preceded by a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use in July (3).
References
Roche. European Commission Approves Roche’s Susvimo for the Treatment of Neovascular Age-Related Macular Degeneration (nAMD). Press Release, Sept. 21, 2026.
Roche. Roche Receives CE Mark for Continue, its Port Delivery Platform Containing Susvimo, for Neovascular Age-Related Macular Degeneration (nAMD). Press Release, Sept. 4, 2026.
Roche. CHMP Recommends EU Approval of Roche’s Susvimo, the First Continuous Delivery Treatment for Neovascular Age-Related Macular Degeneration (nAMD). Press Release July, 24, 2026.