Roche CE mark Contivue advances Susvimo for nAMD in Europe, potentially benefiting 1.7 million people.
• Roche receives CE mark for Contivue on October 2023.
• Platform supports Susvimo for nAMD in Europe.
• Affects approximately 1.7 million people in EU.
Roche has received a CE mark for its Contivue Port Delivery Platform, advancing its ambitions for Susvimo in treating neovascular age-related macular degeneration (nAMD) in Europe. The platform includes an eye implant and four ancillary devices, enabling continuous drug delivery. If approved by European regulatory authorities, it would be the first continuous delivery treatment for nAMD, a condition affecting around 1.7 million people in the EU. Read more.
Why it matters
The approval of the Contivue platform is significant as it offers a new treatment modality for nAMD, potentially reducing the frequency of treatments to as few as two per year. This could improve patient compliance and outcomes. The platform’s sustained delivery mechanism has shown promising results in clinical trials, including the pivotal Phase III Archway study and the Phase II LADDER study. These studies demonstrated that Contivue with Susvimo provides vision outcomes equivalent to monthly intravitreal injections.
What’s next
The European Medicines Agency (EMA) is currently reviewing the combination of Susvimo with Contivue. The review includes data from three clinical studies: Archway, LADDER, and Portal. If approved, this treatment could significantly impact the management of nAMD in Europe. Roche continues to focus on expanding its portfolio and addressing unmet needs in vision loss. For further insights, visit our insights section.