"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
Mechanism of Action
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
The plasma concentration of bromfenac following ocular administration of 0.09% Bromday (bromfenac ophthalmic solution) in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.
Ocular inflammation and pain following cataract surgery
Clinical efficacy was evaluated in three randomized, double-masked, placebo-controlled trials in which subjects requiring cataract surgery were assigned to Bromday (bromfenac ophthalmic solution) or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15. An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery.
In 2 of the 3 studies, Bromday (bromfenac ophthalmic solution) ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46-47% vs. 25-29%) and also had a statistically significant higher incidence of subjects that were pain free at day 1 post cataract surgery (83-89% vs. 51-71%).
Last reviewed on RxList: 11/15/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Bromday Information
- Bromday Drug Interactions Center: bromfenac opht
- Bromday Side Effects Center
- Bromday Overview including Precautions
- Bromday FDA Approved Prescribing Information including Dosage
Bromday - User Reviews
Bromday User Reviews
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