Contivue Port Delivery System Receives CE Mark for Neovascular AMD

Roche has received the CE mark from the European Union for its Contivue port delivery platform, a device-based treatment system containing Susvimo (ranibizumab injection) 100 mg/mL, intended for the treatment of neovascular age-related macular degeneration (nAMD). The platform is currently under review by the European Medicines Agency (EMA).

The Contivue platform consists of an eye implant through which Susvimo is delivered, along with four ancillary devices used for the initial fill, surgical insertion, subsequent refills, and implant removal if necessary. The system allows for the continuous delivery of a customized ranibizumab formulation directly to the eye, designed to reduce the frequency of traditional intravitreal injections.

Clinical Evaluation Through Key Trials

The EMA’s assessment of the platform’s safety and efficacy is based on three clinical studies:

       • The Phase 3 Archway study (NCT03677934)

       • The Phase 2 LADDER study (NCT02510794)

       • The PORTAL long-term extension study (NCT03683251)

Data from Archway showed that patients receiving treatment via Contivue with Susvimo achieved and maintained visual outcomes equivalent to monthly intravitreal ranibizumab injections.

Long-Term Results Support Durability and Efficacy

At the 25th EURETINA Congress, Roche presented seven-year follow-up data from the LADDER study, which highlighted long-term outcomes for 59 patients continuously treated with Contivue with Susvimo. Baseline best-corrected visual acuity (BCVA) averaged 70.4 letters, declining to 63.2 letters after seven years, a reduction of only six letters, which remains favorable compared to the expected decline seen with long-term intravitreal injection regimens.

Additionally, 50% of patients maintained approximately 20/40 vision, and implant durability was preserved in about 95% of cases throughout the study period.

Expert Perspectives on Clinical Impact

“These seven-year results from the LADDER study powerfully demonstrate the long-term outcomes delivered by Contivue with Susvimo,” said Carl C. Awh, MD, FASR, of Tennessee Retina.
“For patients with nAMD, 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.”

According to Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, “Susvimo offers people living with nAMD the opportunity to maintain their vision with as few as two treatments per year.”