Izba
Authorised
This medicine is authorised for use in the European Union
travoprost
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Izba. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Izba.
For practical information about using Izba, patients should read the package leaflet or contact their doctor or pharmacist.
Izba is an eye-drop solution that is used to reduce intraocular pressure (pressure inside the eye) in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) and in adults with ocular hypertension (when the pressure in the eye is higher than normal). It can also be used in children from 3 years of age who have ocular hypertension or childhood glaucoma.
Izba contains the active substance travoprost.
Izba is available as an eye-drop solution (30 microgram/ml) and can only be obtained with a prescription. The dose is one drop of Izba in the affected eye(s) once a day, preferably in the evening.
For further information, see the package leaflet.
When pressure in the eye is raised, it can cause damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain. This can result in serious vision loss and even blindness. By lowering the pressure, Izba reduces the risk of damage.
The active substance in Izba, travoprost, is a prostaglandin analogue (a man-made version of a prostaglandin, substances naturally found in the body). In the eye, prostaglandins increase the drainage of the watery fluid (aqueous humour) out of the eyeball. Izba acts in the same way and increases the flow of fluid out of the eye. This helps to reduce the pressure inside the eye.
An eye-drop solution containing travoprost at a concentration of 40 microgram/ml has been already authorised in the EU as Travatan since 2001. Izba (30 microgram/ml) has been investigated in a main study involving 864 patients with open-angle glaucoma or ocular hypertension, whose average eye pressure was 27 mmHg. The study showed that Izba was as effective as Travatan at reducing pressure in the eye following 2 weeks, 6 weeks and 3 months of treatment. Both medicines were given as one drop in the affected eye once a day, in the evening. In patients taking Izba, the average eye pressure (measured at 8 am in the morning) was 19.4, 19.3 and 19.2 mmHg following 2 weeks, 6 weeks and 3 months of treatment, respectively, which matched the pressure seen at similar time points in patients taking Travatan (19.5, 19.3 and 19.3 mmHg).
Evidence from studies with Izba in adults and with Travatan in children has also been used to work out the effectiveness of Izba in children. In the study of children with glaucoma or ocular hypertension given Travatan, the average eye pressure was reduced by around 27% after 12 weeks. It was calculated that Izba used in children would result in a similar reduction in pressure.
The most common side effect with Izba (which may affect more than 1 in 10 people) is ocular hyperaemia (increased blood supply to the eye, leading to eye irritation and redness)
For the full list of all side effects and restrictions, see the package leaflet.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Izba’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Izba 30 microgram/ml is as effective as the 40 microgram/ml solution of travoprost. The safety profile of Izba seemed more favourable than that of the higher-strength solution, as side effects were less frequent with Izba. Izba is expected to be effective and safe in children from 3 years of age, based on adult studies and a study of 40 microgram/ml travoprost solution in children.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Izba have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Izba on 20 February 2014.
For more information about treatment with Izba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: IA/0015
21/09/2021
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
- Izba
- Active substance
- travoprost
- International non-proprietary name (INN) or common name
- travoprost
- Therapeutic area (MeSH)
- Ocular Hypertension
- Glaucoma, Open-Angle
- Anatomical therapeutic chemical (ATC) code
- S01EE04
Pharmacotherapeutic group
- Ophthalmologicals
- Antiglaucoma preparations and miotics
Therapeutic indication
Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma (see section 5.1). Decrease of elevated intraocular pressure in paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.
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