Contivue port delivery platform for nAMD receives CE mark

(Image credit: ©Symbiot/AdobeStock)

The European Union has granted the EU CE mark to Roche’s port delivery platform, Contivue.¹ This platform contains Susvimo (ranibizumab injection) 100 mg/mL, which is currently under review with the European Medicines Agency (EMA) for the treatment of neovascular AMD (nAMD).¹

Contivue compromises the eye implant through which Susvimo is delivered and four ancillary devices to initially fill, insert, refill, and remove the implant (if required). Contivue with Susvimo provides continuous delivery of a customized formulation of ranibizumab directly to the eye, the company said in a release.¹

The EMA’s evaluation of the safety and efficacy of Contivue with Susimo in AMD is thanks to three clinical studies: one pivotal phase 3 study, Archway (NCT03677934); and two supportive studies, the phase 2 LADDER study (NCT02510794) and the open-label long-term extension study, Portal (NCT03683251).

According to the company, data from Archway demonstrated that patients treated with Contivue with Susimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections.¹

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

Presented during the 25^th European Society of Retina Specialists Annual Congress (EURETINA), seven years of follow-up data from the LADDER study demonstrated good visual outcomes with stable retinal anatomy over the longer term in patients treated with Contivue with Susvimo.

Over seven years, 59 patients were continuously treated with Contivue with Susvimo. The best-corrected visual acuity (BCVA) in these 59 patients was 70.4 letters at baseline and 63.2 letters at seven years—an average decline of only approximately six letters over that time for patients who were at or near peak levels at the time of enrollment after receiving three IVT injections of standard care.¹ Additionally, half of all patients had approximately 20/40 vision at seven years, and Contivue with Susvimo durability was maintained in approximately 95% of patients.¹

“The seven-year results from the LADDER study powerfully demonstrate the long-term outcomes delivered by Contivue with Susvimo,” study investigator Carl C. Awh, MD, FASR, Tennessee Retina, said in a press release.

“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.”

Reference:

1. Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD). Roche.com. Published 2025. Accessed September 4, 2025. https://www.roche.com/media/releases/med-cor-2025-09-04