Yellox - bromfenac

What is Yellox - bromfenac?

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

What is Yellox used for - bromfenac?

Yellox is used to treat postoperative eye inflammation after cataract extraction (clouding of the lens) in adults.
The medicine can only be obtained with a prescription.

How is Yellox used - bromfenac?

The dose of Yellox is one drop in the affected eye (s) twice a day, starting the day after cataract surgery and continuing for two weeks. The duration of treatment should not exceed two weeks.
If more than one ophthalmic medicine is used, the medicines should be administered at least 5 minutes apart.

How does Yellox - bromfenac work?

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

How has Yellox - bromfenac 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 (administration of a pharmacologically inert substance) in 527 patients with postoperative inflammation after cataract surgery. The main measure of effectiveness was the number of patients who showed no signs of inflammation after two weeks.

What benefit has Yellox - bromfenac shown during the studies?

Yellox was more effective than placebo in treating postoperative eye inflammation after cataract extraction. In one study, 66% of patients treated with Yellox (104 out of 158) had no signs of inflammation after two weeks compared with the 48% of patients receiving placebo (35 out of 73). In the second study the results were: 63% (124 out of 198) for patients treated with Yellox and 40% (39 out of 98) for patients receiving placebo.

What are the risks associated with Yellox - bromfenac?

The most common or important side effects of Yellox are abnormal sensation in the eye (0.5%), mild or moderate corneal erosion (of the transparent layer covering the eye) (0.4%), ocular itching (0, 4%), eye pain (0.3%) and eye redness (0.3%). For the full list of side effects reported with Yellox, see the package leaflet.
Yellox must 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 people in whom acetylsalicylic acid (aspirin) or other NSAIDs cause asthma attacks, hives (itchy rash) or acute rhinitis (runny and stuffy nose).

Why has Yellox - bromfenac been approved?

The CHMP decided that the benefits of Yellox outweigh the risks and recommended that it be granted marketing authorization.

More information about Yellox - bromfenac

On 18 May 2011 the European Commission granted Croma-Pharma GmbH a "Marketing Authorization" for Yellox, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For more information on Yellox therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 04-2011.

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