Susvimo

Opinion

EMA has issued an opinion on this medicine

ranibizumab

Overview

On 23 July 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Susvimo, intended for the treatment of neovascular (wet) age-related macular degeneration.

The applicant for this medicinal product is Roche Registration GmbH.

Susvimo will be available as a 100 mg/ml solution for injection delivered via an ocular implant. The active substance of Susvimo is ranibizumab, an antineovascularisation agent (ATC code: S01LA04). Ranibizumab is a monoclonal antibody fragment which modulates angiogenesis by inhibiting vascular endothelial growth factor A. 

The benefits of Susvimo were demonstrated in a phase 3, randomised, visual assessor-masked, active comparator study. Susvimo, continuously released via an implant that is refilled every 24 weeks, was shown to be comparable to intravitreal ranibizumab injections administered every 4 weeks. Treatment with Susvimo led to maintenance of visual and anatomical outcomes with a significant reduction in treatment frequency compared to monthly intravitreal injections of ranibizumab.

The most common side effects are iritis, conjunctival bleb/filtering bleb leak, cataract, vitreous floaters, conjunctival haemorrhage, conjunctival hyperaemia, eye pain and headache.

The full indication is:

Susvimo is indicated in adult patients for the treatment of neovascular (wet) age‑related macular degeneration (nAMD) who have achieved stable disease after previously responding to intravitreal treatment with a vascular endothelial growth factor (VEGF) inhibitor medicinal product.

Susvimo is intended for continuous release into the vitreous using the Contivue ocular implant. It should be administered by an ophthalmologist experienced in vitreoretinal surgery and trained in the implant procedures.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Susvimo

Adopted Reference Number: EMADOC-1829012207-57914

Product details

• Name of medicine:
  Susvimo
• Active substance:
  ranibizumab
• International non-proprietary name (INN) or common name:
  ranibizumab
• Therapeutic area (MeSH):
  Wet Macular Degeneration
• Anatomical therapeutic chemical (ATC) code:
  S01LA04
• EMA product number:
  EMEA/H/C/006527
• Marketing authorisation applicant:
  Roche Registration GmbH
• Opinion adopted:
  23/07/2026
• Opinion status:
  Positive