Roche Receives CE Mark for Contivue Port Delivery Platform with Susvimo in Wet AMD
The European Union (EU) has granted CE mark for Roche's Port Delivery Platform containing Susvimo, which will be branded as Contivue in the EU. Contivue provides sustained ocular drug delivery for patients living with wet age-related macular degeneration (AMD).
The Contivue platform consists of an ocular implant and four ancillary devices designed for implant filling, surgical insertion, in-office refill-exchange, and, if required, implant removal. Susvimo (ranibizumab injection) 100 mg/mL is currently under review by the European Medicines Agency (EMA) for the treatment of wet AMD.
According to Roche, with immediate and predictable durability, Contivue with Susvimo enables continuous intravitreal delivery of a customised formulation of ranibizumab, reducing treatment frequency and potentially transforming the standard of care.
“Susvimo offers people living with wet AMD the opportunity to maintain their vision with as few as two treatments per year,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Moreover, this sustained delivery brings substantial long-term clinical benefits, as demonstrated by the seven years of follow-up data from the LADDER study.”
Three pivotal studies support the EMA’s review:
Archway (Phase 3) – Demonstrated equivalent vision outcomes to monthly intravitreal ranibizumab injections.
LADDER (Phase 2) – Provided long-term efficacy and durability data, with continuous treatment extending up to 7 years.
Portal (open-label extension) – Offered supportive long-term safety and efficacy evidence
Data presented at the 25th EURETINA Congress (Paris, France) highlighted 7-year outcomes from LADDER:
Visual Outcomes: Mean best-corrected visual acuity (BCVA) declined by only 6 letters, from 70.4 at baseline to 63.2 at year 7
Functional Vision: ~50% of patients maintained approximately 20/40 Snellen vision at 7 years
Durability: Implant function was maintained in ~95% of patients
“The seven-year results from the LADDER study powerfully demonstrate the long-term outcomes delivered by Contivue with Susvimo,” said study investigator Carl C. Awh, MD, FASR, of Tennessee Retina, Nashville. “For patients with wet AMD, the sustained drug delivery of Contivue with Susvimo may provide superior visual outcomes compared to the well-demonstrated average decline in vision associated with long-term intravitreal injections.”
Roche said it also has additional molecules in its pipeline under evaluation for use with the Contivue platform, aiming to broaden its application across other retinal diseases.