BASEL, Switzerland, July 24, 2026
Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation supporting the approval of Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of neovascular age-related macular degeneration (nAMD). The recommendation brings Susvimo, the first and only continuous drug delivery treatment for wet AMD, one step closer to commercialization across the European Union, with a final decision from the European Commission expected in the coming months. Delivered through the Contivue® refillable eye implant, Susvimo continuously releases medicine into the eye and offers patients an alternative to frequent intravitreal injections by requiring as few as two refill treatments per year. The milestone represents a significant advancement in ophthalmology, aiming to reduce treatment burden while maintaining long-term vision outcomes for patients affected by one of the leading causes of blindness in older adults.
Clinical Studies Demonstrate Long-Term Vision Preservation
The CHMP recommendation is supported by robust clinical evidence from the Phase III Archway trial, the Phase II LADDER study, and the long-term Portal extension study. Across these studies, Susvimo consistently maintained vision outcomes equivalent to monthly intravitreal ranibizumab injections, the current standard of care for patients with neovascular age-related macular degeneration. Long-term follow-up data from the Portal study further demonstrated that patients maintained stable vision for up to seven years, highlighting the durability of continuous drug delivery through the implant system. Approximately 95% of patients receiving Susvimo required no supplemental anti-VEGF therapy between scheduled refills, confirming the treatment’s ability to provide sustained disease control while significantly reducing the frequency of clinical interventions. Throughout the clinical program, Susvimo demonstrated a favorable safety profile, reinforcing its potential as an effective long-term therapeutic option.
Contivue Implant Offers Continuous Drug Delivery Innovation
Unlike conventional therapies requiring frequent eye injections, Contivue® utilizes a refillable ocular implant that is surgically inserted during a one-time outpatient procedure and continuously delivers a customized formulation of ranibizumab directly into the vitreous. The implant is specifically engineered to provide controlled release of medication over extended periods while minimizing treatment interruptions. Roche received the CE Mark for the Contivue Port Delivery Platform in 2025, validating the safety and performance of the implant and its associated refill, insertion, and removal devices. Beyond Susvimo, Roche is actively evaluating additional therapeutic molecules that could be delivered through the Contivue platform to improve treatment durability and expand options for patients with retinal diseases. This platform-based strategy reflects Roche’s broader commitment to advancing continuous drug delivery technologies that enhance convenience while maintaining clinical effectiveness..
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Potential to Transform Care for Patients with Wet AMD
Neovascular age-related macular degeneration affects approximately 20 million people worldwide, including nearly 1.7 million individuals across the European Union, and remains one of the leading causes of irreversible vision loss among people over the age of 60. Current anti-VEGF therapies often require monthly or frequent injections, creating a substantial treatment burden for patients, caregivers, and healthcare systems. If granted final approval by the European Commission, Susvimo would become the first continuous delivery treatment available in Europe for wet AMD, offering a significant advancement in disease management by reducing clinic visits while maintaining visual outcomes comparable to standard monthly injections. The positive CHMP opinion further strengthens Roche’s leadership in ophthalmology innovation, supporting its long-term strategy to develop next-generation therapies that preserve vision and improve quality of life for patients living with retinal diseases.
Source: Roche press release
