Roche receives EU CE mark for Contivue for neovascular age-related macular degeneration
Basel: Roche has announced that it has received the EU CE mark for its Port Delivery Platform containing Susvimo, which will now be known as Contivue in the EU. The device comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill, and remove the implant (if required).
Susvimo (ranibizumab injection) 100 mg/mL is currently under review with the European Medicines Agency (EMA) for the treatment of neovascular age-related macular degeneration(nAMD. With immediate and predictable durability, Contivue with Susvimo provides continuous delivery of a customised formulation of ranibizumab directly to the eye.
“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.”
Three clinical studies contribute to the EMA’s evaluation of efficacy and safety of Contivue with Susvimo in nAMD: one pivotal Phase III study, Archway, and two supportive studies, the Phase II LADDER study and the open-label long-term extension study Portal. Data from Archway showed patients treated with Contivue with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections.
New long-term data from the LADDER study, presented at the 25th EURETINA Congress in Paris, France, shows that Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term. In the 59 patients continuously treated with Contivue with Susvimo over seven years, best-corrected visual acuity (BCVA) was 70.4 letters at baseline and 63.2 letters at seven years, an average decline of only seven letters approximately over that time for patients who were at or near peak levels at the time of enrolment after receiving three intravitreal injections of standard of care. Half of all patients had approximately 20/40 vision at seven years (Snellen visual acuity test). Contivue with Susvimo durability was maintained in approximately 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 devices have been specifically engineered for use with a customized formulation of ranibizumab that is gradually released over time. Roche has several molecules in the pipeline with potential for use with the port delivery platform for continued growth and expansion.
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or ‘wet’ AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated. It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis. Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.
