Roche has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Susvimo® (ranibizumab) for the treatment of neovascular age-related macular degeneration (nAMD). If the European Commission grants final approval, Susvimo will become the first continuous drug-delivery treatment for nAMD in the European Union.
Unlike conventional anti-VEGF therapies that require frequent intravitreal injections, Susvimo uses a refillable ocular implant to continuously deliver ranibizumab over several months. Clinical studies demonstrated that the therapy maintains vision outcomes comparable to monthly injections while significantly reducing the treatment burden for patients and healthcare providers.
The positive CHMP recommendation is based on evidence from Roche's clinical development program, which showed sustained efficacy, a well-characterized safety profile, and the potential to improve long-term adherence to treatment. Following this recommendation, the European Commission will make the final marketing authorization decision applicable across EU member states.
Susvimo is designed for people with wet AMD, a leading cause of irreversible vision loss in older adults. By providing continuous intraocular drug delivery through an implanted reservoir that can be refilled during scheduled office visits, the therapy aims to reduce the need for frequent eye injections while preserving visual outcomes.
