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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/244009/2011

EMEA/H/C/001198

EPAR summary for the public

Yellox

bromfenac

This is a summary of the European public assessment report (EPAR) for Yellox. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Yellox.

What is Yellox?

Yellox is an eye drop solution that contains the active substance bromfenac.

What is Yellox used for?

Yellox is used in adults to treat inflammation in the eye that occurs after an operation to remove a cataract (clouding of the lens).

The medicine can only be obtained with a prescription.

How is Yellox used?

The dose of Yellox is one drop into the affected eye(s) twice a day beginning the day after the cataract operation and continued for two weeks. Treatment should not exceed two weeks.

If more than one eye medicine is being used, they should be given at least five minutes apart.

How does Yellox work?

The active substance in Yellox, bromfenac, is a non-steroidal anti-inflammatory drug (NSAID). It works by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process. By reducing the production of prostaglandins in the eye, Yellox can reduce the inflammation caused by eye surgery.

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How has Yellox been studied?

The effects of Yellox were first tested in experimental models before being studied in humans.

In two main studies Yellox was compared with placebo (a dummy treatment) in 527 patients with inflammation following cataract surgery. The main measure of effectiveness was the number of patients with no signs of inflammation after two weeks.

What benefit has Yellox shown during the studies?

Yellox was more effective than placebo in treating inflammation in the eye following cataract surgery.

In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73). In the second study, the figures were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for those treated with placebo.

What is the risk associated with Yellox?

The most common or most important side effects seen with Yellox are abnormal sensation in eye (0.5%), mild or moderate erosion of the cornea (the transparent layer in front of the eye) (0.4%), eye pruritus (itching) (0.4%), eye pain (0.3%) and eye redness (0.3%). For the full list of all side effects reported with Yellox, see the package leaflet.

Yellox should not be used in people who may be hypersensitive (allergic) to bromfenac, to any of the other ingredients or to other NSAIDs. It must not be used in patients who get asthma attacks, urticaria (itchy rash) or acute rhinitis (stuffy and runny nose) from taking acetylsalicylic acid (aspirin) or other NSAIDs.

Why has Yellox been approved?

The CHMP decided that Yellox's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Yellox

The European Commission granted a marketing authorisation valid throughout the European Union for Yellox to Croma-Pharma GmbH on 18 May 2011. The marketing authorisation is valid for five years, after which it can be renewed.

The full EPAR for Yellox 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 Yellox, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011.

Yellox

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