What is Izba and what is it used for?
Izba is an eye drop solution containing the active substance travoprost . It is used to reduce intraocular pressure (pressure inside the eye) in adults with open-angle glaucoma (a disease in which eye pressure increases because the liquid cannot flow out of the eye) and in affected adults from ocular hypertension (eye pressure higher than normal).
How is Izba used - travoprost?
Izba is available as an eye drop solution (30 micrograms / ml) and can only be obtained with a prescription. The dose is one drop of Izba in the affected eye or eyes once a day, preferably in the evening. For more information, see the package leaflet.
How does Izba - travoprost work?
When the pressure in the eye increases, it causes damage to the retina (the light-sensitive membrane located in the back of the eye) and to the optic nerve that sends signals from the eye to the brain, It can result in severe vision loss and even blindness. By lowering the pressure, Izba reduces the risk of injury.
The active substance in Izba, travoprost, is an analogue of prostaglandins (an artificial copy of a prostaglandin, a substance naturally found in the body). In the eye prostaglandins increase the drainage of aqueous humor (transparent liquid present inside the eye) towards the outside. Izba acts in a similar way and increases the flow of aqueous humor towards the outside of the eye and thereby helps to reduce intraocular pressure.
What benefit has Izba - travoprost shown during the studies?
An eye drop solution containing travoprost at a concentration of 40 micrograms / ml has already been authorized in the EU under the name Travatan since 2001. Izba (30 micrograms / ml) has been studied in a main study involving 864 patients with open-angle glaucoma or ocular hypertension, whose average ocular pressure was 27mmHg. The study showed that Izba was as effective as Travatan in reducing eye pressure after 2 weeks, 6 weeks and 3 months of treatment. Both drugs had been administered in the affected eye in one drop drop once a day in the evening. In patients taking Izba the eye pressure (measured at 8 am) was 19.4, 19.3 and 19.2 mmHg after 2 weeks, 6 weeks and 3 months of treatment respectively, which corresponded to the pressure detected at similar times in patients treated with Travatan (19.5, 19.3 and 19.3 mmHg).
What is the risk associated with Izba - travoprost?
The most common side effects associated with Izba (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood flow in the eye, which causes redness and irritation). For the full list of side effects and limitations, see the package leaflet.
Why has Izba - travoprost been approved?
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 micrograms / ml is as effective as the travoprost solution of 40 micrograms / ml. The safety profile of Izba seemed better than that of the more concentrated solution, as the side effects were less frequent with Izba.
What measures are being taken to ensure the safe and effective use of Izba - travoprost?
A risk management plan has been developed to ensure that Izba is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Izba, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Izba - travoprost
On 20 February 2014, the European Commission issued a marketing authorization for Izba, valid throughout the European Union. For more information about treatment with Izba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 02-2014.
