EU approves Roche's Susvimo eye implant for macular disease

The European Commission has approved Roche's Susvimo, a ranibizumab 100 mg/mL solution for injection, to treat neovascular age-related macular degeneration (nAMD). The condition affects roughly 1.7 million individuals across the European Union and around 20 million people worldwide, serving as a primary cause of vision loss in adults over 60.

Susvimo delivers medicine continuously through the Contivue refillable ocular implant, which received a CE mark in 2025 alongside four ancillary surgical devices. The system allows patients to maintain vision with as few as two refills each year, providing an alternative to standard monthly intravitreal injections. Roche noted that 40% of nAMD patients typically discontinue standard treatment within two years.

The regulatory green light followed data from three trials: the Phase III Archway study, the Phase II Ladder trial, and the Portal extension study. Archway demonstrated vision maintenance equivalent to monthly ranibizumab injections, with Portal tracking outcomes for up to seven years. Across the program, approximately 95% of patients required no supplemental anti-VEGF therapy when receiving two refills per year.

Susvimo is already approved in the United States, Switzerland, and Thailand. Roche stated it is also evaluating other pipeline molecules for use with the Port Delivery Platform.