What is Yellox - bromfenac?
Yellox is an eye drop in solution that contains the active ingredient bromfenac.
What is Yellox - bromfenac used for?
Yellox is used for the treatment of postoperative ocular inflammation after cataract extraction (lens opacification) in adults.
The medicine can only be obtained with a prescription.
How is Yellox - bromfenac used?
The dose of Yellox is one drop in the affected eye or eyes twice a day, starting from the day after the cataract surgery and continuing for two weeks. The duration of treatment should not exceed two weeks.
If more than one ophthalmic medicinal product 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.
What studies have been performed on Yellox - bromfenac?
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 suffering from postoperative inflammation after cataract surgery. The main efficacy index 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 the treatment of postoperative ocular inflammation after cataract extraction. In one study, 66% of patients treated with Yellox (104 out of 158) showed no signs of inflammation after two weeks compared with 48% of patients receiving placebo (35 out of 73). In the second study the results were: 63% (124 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 most important side effects of Yellox are abnormal sensation in the eye (0.5%), corneal erosion (of the transparent layer covering the eye) mild or moderate (0.4%), ocular 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 excipients or to other NSAIDs. It must not be used in subjects in whom acetylsalicylic acid (aspirin) or other NSAIDs cause asthma attacks, urticaria (rash itch) or acute rhinitis (a stuffy and dripping nose).
Why has Yellox - bromfenac been approved?
The CHMP decided that Yellox's benefits outweigh the risks and recommended granting a marketing authorization.
More information on Yellox - bromfenac
On 18 May 2011, the European Commission issued a marketing authorization for Yellox to Croma-Pharma GmbH, 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 (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 04-2011.
