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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/807134/2013

EMEA/H/C/002738

EPAR summary for the public

Izba

travoprost

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.

What is Izba and what is it used for?

Izba is an eye-drop solution that contains the active substance travoprost. It 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).

How is Izba used?

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.

How does Izba work?

When pressure in the eye is raised, it causes 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

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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.

What benefits of Izba have been shown in studies?

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).

What are the risks associated with Izba?

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.

Why is Izba 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 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.

What measures are being taken to ensure the safe and effective use of Izba?

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 can be found in the summary of the risk management plan.

Other information about Izba

The European Commission granted a marketing authorisation valid throughout the European Union for Izba on 20 February 2014.

The full EPAR and risk management plan summary for Izba can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Izba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2014.

Izba

EMA/807134/2013