Susvimo
Authorised
This medicine is authorised for use in the European Union
ranibizumab
MedicineHumanAuthorised
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Susvimo is a medicine used in adults to treat neovascular (wet) age-related macular degeneration (nAMD). It is used in people whose disease is stable after responding to intravitreal treatment (delivered into the vitreous humour, the jelly-like fluid in the eye) with a medicine called a vascular endothelial growth factor (VEGF) inhibitor.
The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, the light-sensing layer at the back of the eye, which may leak fluid and blood and cause swelling).
Susvimo contains the active substance ranibizumab.
Susvimo can only be obtained with a prescription. It is only to be used in combination with an implant that is surgically inserted into the eye and refilled every six months. Appropriately trained eye specialists should insert and refill the implant.
For more information about Susvimo, see the package leaflet or contact your doctor.
The active substance in Susvimo, ranibizumab, is a small piece of a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific target (called an antigen) that is found in certain cells in the body.
Ranibizumab has been designed to attach to and block a substance called vascular endothelial growth factor A (VEGF-A). VEGF-A is a protein that makes blood vessels grow and leak fluid and blood, damaging the macula. By blocking VEGF-A, ranibizumab reduces the growth of the blood vessels and controls the leakage and swelling.
Susvimo was investigated in one main study involving 415 adults with nAMD whose disease was stable after at least three intravitreal treatments with a VEGF inhibitor medicine.
People received either Susvimo via an eye implant refilled every six months or intravitreal injections of ranibizumab every four weeks. The main measure of effectiveness was the change in the number of letters that people could recognise in an eye test at weeks 36 and 40, compared with the number of letters before starting treatment. Being able to recognise more letters indicates an improvement in vision.
The results showed that vision remained broadly stable in both groups. The average change in the number of letters people could read was +0.2 letters with Susvimo compared with +0.5 letters with monthly ranibizumab injections.
Studies carried out with Susvimo are described in more detail in the medicine’s assessment report.
For the full list of side effects and restrictions with Susvimo, see the package leaflet.
The most common side effects with Susvimo (which may affect more than 1 in 10 people) include conjunctival haemorrhage (bleeding at the front of the eye), conjunctival hyperaemia (increased blood supply to the eye, leading to redness), iritis (inflammation of the iris), eye pain, cataract (clouding of the lens), conjunctival bleb/filtering bleb leak (a small bulge in the conjunctiva, with or without fluid leaking), vitreous floaters (spots in the vision) and headache.
Susvimo must not be used in patients who may have an infection of the eye or of the area around the eye, or who have severe inflammation in the eye.
The main study showed that Susvimo maintained vision as effectively as ranibizumab injections given every four weeks, while reducing how often treatment was needed. Although treatment with Susvimo is associated with a higher risk of side effects compared with intravitreal injections of ranibizumab, most of these are manageable with routine medical treatment and are outweighed by the medicine’s benefits and the reduced requirement for frequent treatments.
The European Medicines Agency therefore decided that Susvimo’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Susvimo will provide information to eye specialists on the procedures for insertion, removal and refill‑exchange of the implant, and educational materials to patients to help them prepare for treatment, recognise serious side effects and know when to seek urgent medical attention.
These materials may be made available by national competent authorities on their websites. A list of national repositories is available on the EMA website.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Susvimo have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Susvimo are continuously monitored. Suspected side effects reported with Susvimo are carefully evaluated and any necessary action is taken to protect patients.
Susvimo received a marketing authorisation valid throughout the EU on 18 September 2026.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Pharmacotherapeutic group
OphthalmologicalsTherapeutic indication
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.
News on Susvimo
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