Roche has received the EU CE mark for its Port Delivery Platform containing Susvimo®, now branded as Contivue® in Europe. The platform consists of an eye implant for continuous drug delivery, supported by four ancillary devices for filling, insertion, refill, and removal when required.
Susvimo® (ranibizumab injection) 100 mg/mL is currently under review by the European Medicines Agency (EMA) for treating neovascular age-related macular degeneration (nAMD). Contivue with Susvimo delivers a customized formulation of ranibizumab directly to the eye, offering immediate and predictable durability.
“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 evaluation of Contivue with Susvimo is supported by:
Archway (Phase III pivotal study) – Demonstrated equivalent vision outcomes to monthly intravitreal injections.
LADDER (Phase II study) – Provided long-term efficacy and durability data.
Portal (open-label extension study) – Supported sustained outcomes.
At the 25th EURETINA Congress in Paris, seven-year results from LADDER showed:
Stable visual outcomes with minimal decline (average six letters over seven years).
Half of patients maintained ~20/40 vision.
Durability sustained 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, 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.’’
The Port Delivery Platform was designed for a customized ranibizumab formulation, gradually releasing the drug over time. Roche is also developing additional molecules for potential use with this platform, aiming to expand sustained delivery therapies across ophthalmology.