Epruvy (previously Ranibizumab Midas)
Authorised
This medicine is authorised for use in the European Union
ranibizumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Ranibizumab Midas is a medicine used to treat adults with certain sight problems caused by damage to the retina (the light-sensing layer at the back of the eye), and more specifically its central region, known as the macula. The macula provides the vision needed to see detail for everyday tasks such as driving, reading and recognising faces. Ranibizumab Midas is used to treat:
- ‘wet’ form of age-related macular degeneration (AMD). The wet form of AMD is caused by choroidal neovascularisation (abnormal growth of blood vessels beneath the retina, which may leak fluid and blood and cause swelling);
- macular oedema (swelling of the macula) caused by diabetes or by occlusion (blockage) of the veins behind the retina;
- proliferative diabetic retinopathy (growth of abnormal tiny blood vessels in the eye, associated with diabetes);
- other sight problems associated with choroidal neovascularisation.
Ranibizumab Midas contains the active substance ranibizumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Ranibizumab Midas is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Ranibizumab Midas is Lucentis. For more information on biosimilar medicines, see here.
Ranibizumab Midas is given by intravitreal injection (injection into the vitreous humour, the jelly-like fluid in the eye). It can only be obtained with a prescription and must be given by a qualified eye doctor who is experienced in giving intravitreal injections.
Treatment with Ranibizumab Midas is started with one injection every month, with regular checks of the patient’s vision and examination of the back of the eye, until maximum vision is achieved and/or there are no signs of disease activity. The interval between two injections of Ranibizumab Midas into the same eye must be at least four weeks. Treatment with Ranibizumab Midas should be stopped if the patient is not benefitting from it.
For more information about using Ranibizumab Midas, see the package leaflet or contact your doctor or pharmacist.
The active substance in Ranibizumab Midas, 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.
Laboratory studies comparing Ranibizumab Midas with Lucentis have shown that the active substance in Ranibizumab Midas is highly similar to that in Lucentis in terms of structure, purity and biological activity. Studies have also shown that giving Ranibizumab Midas produces similar levels of the active substance in the body to giving Lucentis.
In addition, a study involving 477 people with age-related macular degeneration found that Ranibizumab Midas produced improvements in the condition comparable to those seen with Lucentis. In this study, the average number of letters patients could recognise on a standard eye test improved by 5 in patients treated with Ranibizumab Midas and by 6 in patients given Lucentis after 8 weeks of treatment.
Because Ranibizumab Midas is a biosimilar medicine, the studies on effectiveness and safety of ranibizumab carried out with Lucentis do not all need to be repeated for Ranibizumab Midas.
The safety of Ranibizumab Midas has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Lucentis.
For the complete list of side effects and restrictions of Ranibizumab Midas, see the package leaflet.
The most common side effects with ranibizumab (which may affect more than 1 in 10 people) include increased intraocular pressure (pressure within the eye), headache, vitritis (inflammation in the eye), vitreous detachment (separation of the vitreous from the back of the eye), retinal haemorrhage (bleeding at the back of the eye), visual disturbance, eye pain, vitreous floaters (spots in the vision), conjunctival haemorrhage (bleeding at the front of the eye), eye irritation, sensation of a foreign body in the eye, increased lacrimation (watery eyes), blepharitis (inflammation of the eyelids), dry eye, ocular hyperaemia (increased blood supply to the eye, leading to redness of the eye), eye pruritis (itching), arthralgia (joint pain) and nasopharyngitis (inflammation of the nose and throat). Rarely, endophthalmitis (an infection inside the eye), blindness, serious damage to the retina and cataract (clouding of the lens) can occur.
Ranibizumab Midas 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.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Ranibizumab Midas has a highly similar structure, purity and biological activity to Lucentis and is distributed in the body in the same way. In addition, a study in age-related macular degeneration has shown that Ranibizumab Midas and Lucentis are equivalent in terms of safety and effectiveness in this use.
All these data were considered sufficient to conclude that Ranibizumab Midas will have the same effects as Lucentis in its authorised uses. Therefore, the Agency’s view was that, as for Lucentis, the benefits of Ranibizumab Midas outweigh the identified risks and it can be authorised for use in the EU.
The company that markets Ranibizumab Midas will provide information packs to patients to help them prepare for treatment, recognise serious side effects and know when to seek urgent medical attention.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ranibizumab Midas have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ranibizumab Midas are continuously monitored. Suspected side effects reported with Ranibizumab Midas are carefully evaluated and any necessary action taken to protect patients.
Ranibizumab Midas received a marketing authorisation valid throughout the EU on 19 September 2024.
Product information
Latest procedure affecting product information:
VR/0000246812
06/02/2025
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
- Epruvy (previously Ranibizumab Midas)
- Active substance
- ranibizumab
- International non-proprietary name (INN) or common name
- ranibizumab
- Therapeutic area (MeSH)
- Wet Macular Degeneration
- Macular Edema
- Choroidal Neovascularization
- Diabetes Complications
- Anatomical therapeutic chemical (ATC) code
- S01LA04
Pharmacotherapeutic group
OphthalmologicalsTherapeutic indication
Treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularisation (CNV).
News on Epruvy (previously Ranibizumab Midas)
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