Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD)

• usvimo is under review with the EMA and once approved will be the first continuous delivery treatment for nAMD, affecting 1,7 million in the European Union¹
• New seven-year data from the LADDER study show Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer term²
• With up to two refills per year, Contivue with Susvimo provides reliable, long-term vision outcomes and is approved in the US for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR)^2-5

Basel, 04 September 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.⁶ 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).⁶ Susvimo® (ranibizumab injection) 100 mg/mL is currently under review with the European Medicines Agency (EMA) for the treatment of nAMD.⁶ With immediate and predictable durability, Contivue with Susvimo provides continuous delivery of a customised formulation of ranibizumab directly to the eye.⁶

“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.⁷

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.² 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 six 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.² 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.²

“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.

About neovascular age-related macular degeneration
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.^8-10 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.¹⁰ 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.^{8, 11-12}

About Contivue with Susvimo (Port Delivery Platform with ranibizumab)
Contivue is a refillable eye implant surgically implanted into the eye during a one-time, outpatient procedure.^2-4,13 Contivue also includes four ancillary devices to initially fill, insert, refill, and remove the implant.

Contivue with Susvimo delivers a customised formulation of ranibizumab, Susvimo, over time.⁵ Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.^2-4,14 The customised formulation of ranibizumab, Susvimo, delivered by Contivue with Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis® (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.¹⁵

In the US, the devices (refillable eye implant and ancillary devices) and medicine (customised formulation of ranibizumab) are approved by the Food and Drug Administration (FDA) as a single product, called Susvimo for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR).^2-4