Vabysmo
Authorised
This medicine is authorised for use in the European Union
faricimab
MedicineHumanAuthorised
Overview
Vabysmo is a medicine used to treat adults with:
- the ‘wet’ form of age-related macular degeneration (AMD), a disease that affects the central part of the retina (called the macula) at the back of the eye. The wet form of AMD is caused by abnormal growth of blood vessels beneath the retina which may leak fluid and blood and cause swelling;
- impaired vision due to macular oedema caused by diabetes.
The macula provides central vision that is needed to see details for everyday tasks such as driving, reading and recognising faces. The diseases cause the gradual loss of the central part of a person’s vision.
Vabysmo contains the active substance faricimab.
Vabysmo can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving injections into the eye.
It is given as an injection into the vitreous humour, the jelly-like fluid inside the eye. Treatment starts with one injection of 6 mg every four weeks. After four doses, the doctor may adjust the interval after assessing the patient’s vision. Treatment with Vabysmo should be stopped if the patient is not benefitting from it.
For more information about using Vabysmo, see the package leaflet or contact your doctor or pharmacist.
The active substance in Vabysmo, faricimab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to two proteins: vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). In patients with wet AMD and diabetic macular oedema, these proteins stimulate the abnormal growth of blood vessels that is associated with fluid and blood leakage, which damages the macula. By attaching to VEGF-A and Ang-2, faricimab blocks the action of these proteins, thereby reducing the growth of the blood vessels and controlling the leakage, swelling and inflammation.
AMD
Two main studies involving 1,329 patients with the wet form of AMD showed that Vabysmo given at up to 16-week intervals was at least as effective at improving the condition as aflibercept (another medicine for the wet form of AMD) given at 8-week intervals. After a year of treatment, the average number of letters patients could recognise on a standard eye test improved by 5.8 (first study) and 6.6 letters (second study) in patients treated with Vabysmo, and by 5.1 and 6.6 letters for those given aflibercept.
Diabetic macular oedema
Two further main studies involving 1,891 patients with diabetic macular oedema looked at the effect of Vabysmo given either at 8-week intervals or at adjustable intervals (up to 16 weeks), and of aflibercept at 8-week intervals.
After a year of treatment, the improvement in the number of letters patients could recognise was similar for the different treatments. In the first study, this improved by 10.7 letters for patients given Vabysmo every 8 weeks, by 11.6 letters for those given Vabysmo at variable intervals, and by 10.9 letters for those given aflibercept. In the second study, the improvements were 11.8, 10.8 and 10.3 letters, respectively. In both studies, this effect was maintained throughout a second year of treatment.
The most common side effect with Vabysmo (which may affect up to 2 in 10 people) is cataract (clouding of the lens). Other common side effects (which may affect up to 1 in 10 people) are bleeding of the conjunctiva (the membrane that lines the white of the eye and the inside of the eyelid), increased pressure within the eye, vitreous floaters (small, dark shapes moving in the field of vision), eye pain, tears of the retinal pigment epithelium (only in patients with wet AMD) and increased lacrimation (watery eyes).
The most serious side effects are uveitis (inflammation of the uvea, the layer beneath the white of the eyeball), vitritis (the presence of inflammatory cells in the vitreous humour), endophthalmitis (inflammation inside the eye), retinal tear and rhegmatogenous retinal detachment (the most common type of retinal detachment).
Vabysmo 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 within the eye. For the full list of side effects and restrictions of Vabysmo, see the package leaflet.
Vabysmo was shown to be as effective as the comparator aflibercept at improving the vision of patients with wet AMD and diabetic macular oedema. With regards to safety, the most common side effects of Vabysmo are similar to those of other products given by intravitreal injection.
The European Medicines Agency therefore decided that Vabysmo’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Vabysmo will complete two studies to confirm the safety of the medicine when used long term.
The company will also provide information packs to patients to help them prepare for treatment, recognise serious side effects and know when to seek urgent attention from their doctor.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vabysmo have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Vabysmo are continuously monitored. Suspected side effects reported with Vabysmo are carefully evaluated and any necessary action taken to protect patients.
Vabysmo received a marketing authorisation valid throughout the EU on 15 September 2022.
This overview was last updated in 09-2022.
Product information
Latest procedure affecting product information: II/0009
08/02/2024
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
- Vabysmo
- Active substance
- Faricimab
- International non-proprietary name (INN) or common name
- faricimab
- Therapeutic area (MeSH)
- Wet Macular Degeneration
- Macular Edema
- Diabetes Complications
- Anatomical therapeutic chemical (ATC) code
- S01L
Pharmacotherapeutic group
OphthalmologicalsTherapeutic indication
Vabysmo is indicated for the treatment of adult patients with:
- neovascular (wet) age-related macular degeneration (nAMD),
- visual impairment due to diabetic macular oedema (DME).
News on Vabysmo
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