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

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  • The European Commission has approved Susvimo (ranibizumab 100 mg/mL solution) for treating neovascular age-related macular degeneration (nAMD) in people over 60.
  • Susvimo is the first continuous delivery treatment for nAMD, utilizing the Contivue refillable implant to deliver medicine directly into the eye.
  • The treatment requires as few as two refills per year, offering an alternative to standard monthly or bi-monthly intravitreal injections.
  • Phase III Archway study data showed Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections.
  • Long-term data from the Portal study indicated that vision was maintained for up to seven years with Susvimo.
  • Approximately 95% of patients treated with Susvimo required no supplemental anti-VEGF treatment over the long term.
  • nAMD affects approximately 1.7 million people in the European Union and is a leading cause of vision loss in adults over 60.
  • The Contivue platform includes the refillable implant and four ancillary devices for initial filling, insertion, refilling, and removal.
  • Susvimo uses a customized formulation of ranibizumab that differs from the injectable version marketed as Lucentis.
  • The approval is based on data from the Archway Phase III study, the Ladder Phase II study, and the Portal long-term extension study.
  • Susvimo with Contivue is also approved for nAMD treatment in Switzerland, Thailand, and the United States.