EMA Recommends EU Approval of Susvimo as New Treatment Option for Wet Age-Related Macular Degeneration
July 24, 2026 — The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union for Susvimo (ranibizumab) to treat adults with neovascular (wet) age-related macular degeneration (nAMD), offering a new treatment option that reduces the burden of frequent eye injections.
Susvimo is delivered via a refillable ocular implant, the first of its kind approved in the EU. The implant is surgically inserted into the eye and designed to release ranibizumab continuously over time, requiring refilling only every six months. This provides an alternative to the current standard of care, which involves intravitreal injections typically administered every four weeks.
The recommendation is specifically for patients whose nAMD is stable after responding to prior treatment with a vascular endothelial growth factor (VEGF) inhibitor medicine.
AMD is a chronic, progressive disease of the macula and a leading cause of central vision loss among people over 50. nAMD, if left untreated, causes rapid and severe vision loss. While ranibizumab-containing medicines have been authorised in the EU since 2007, the frequent injection schedule and associated clinic visits can affect treatment compliance over time.
A Phase 3 study involving 415 patients with nAMD showed that Susvimo was comparable to monthly intravitreal ranibizumab injections in maintaining visual and anatomical outcomes. Common side effects included iritis, conjunctival bleb leak, cataract, vitreous floaters, conjunctival haemorrhage, conjunctival hyperaemia, eye pain and headache.
The CHMP opinion will now be sent to the European Commission for adoption of a decision on EU-wide marketing authorisation. Pricing and reimbursement decisions will be made at the level of each Member State. The applicant for Susvimo is Roche Registration GmbH.
