Committee’s positive opinion supports a new, less burdensome treatment option for patients with the leading cause of vision loss in individuals over 60 years old.
The European Medicines Agency’s committee for Medicinal Products for Human Use (CHMP) has given a nod of approval for the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD).
Roche’s Susvimo® (ranibizumab injection) 100 mg/mL provides an alternative to standard of care eye injections for nAMD. Administered via the Contivue implant, the port delivery system was granted a CE mark in the EU last September.
Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “The positive CHMP recommendation for Susvimo brings us closer to offering a new treatment option for people in Europe who currently face the burden of frequent eye injections.
“By requiring only two refills per year, Contivue with Susvimo offers a continuous drug delivery approach intended to reduce the frequency of clinic visits, with data from clinical trials supporting maintenance of vision up to seven years.”
“By requiring only two refills per year, Contivue with Susvimo offers a continuous drug delivery approach intended to reduce the frequency of clinic visits, with data from clinical trials supporting maintenance of vision up to seven years”
Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development
The CHMP’s recommendation is based on data from Phase III study Archway, as well as the Phase II LADDER study and Portal, a long-term extension study.
The FDA approved Susvimo in May 2025. According to five-year data presented at the American Society of Retina Specialists (ASRS) 2025 Annual Meeting, approximately 95 percent of patients required no supplemental/additional anti-vascular endothelial growth factor (anti-VEGF) treatment with Susvimo.
Prior to this recommendation by the CHMP, Roche agreed to pay a license fee of up to $2.3 billion for Nurix Therapeutics’ bexobrutideg (NX-5948), a Bruton’s tyrosine kinase (BTK) degrader with best-in-class potential in B-cell malignancies.
Roche’s Chief Medical Officer and Head of Global Product Development, remarked that bexobrutideg “could represent a major leap forward in the fight against complex blood cancers and other diseases.”
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