Roche Receives EU CE Mark For Contivue®, The Port Delivery Platform With Susvimo Maintains Vision Outcomes In nAMD Patients

Roche, announced it has received the EU CE mark for its Port Delivery Platform with Susvimo, now branded as Contivue® in the European Union. The device includes an eye implant that delivers Susvimo (ranibizumab injection, 100 mg/mL) and four ancillary tools for filling, insertion, refilling, and removal if needed. Susvimo is currently under review by the European Medicines Agency (EMA) for the treatment of neovascular age-related macular degeneration (nAMD). Contivue offers continuous and predictable drug delivery directly to the eye, reducing the need for frequent injections.

“Susvimo offers people living with nAMD 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.”

The EMA’s review is supported by three key studies: the pivotal Phase III Archway trial, the Phase II LADDER study, and the long-term Portal extension study. Data from Archway showed that patients treated with Contivue achieved and maintained vision outcomes equivalent to those receiving monthly intravitreal ranibizumab injections, confirming its efficacy and safety.

“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, Tennessee Retina, Nashville, TN, USA . “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.’’

Long-term results from the LADDER study, presented at the 25th EURETINA Congress in Paris, further demonstrated durability and stable vision outcomes. In 59 patients treated continuously with Contivue over seven years, best-corrected visual acuity (BCVA) declined only modestly, from 70.4 letters at baseline to 63.2 letters, with nearly 50% of patients maintaining 20/40 vision. Contivue durability was preserved in 95% of patients. Roche is also advancing additional molecules for use with the port delivery platform to expand treatment options in ophthalmology.