July 29, 2016
Recommended Topic Related To:


"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 (COX) 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 0.07% PROLENSA (bromfenac ophthalmic solution) in humans is unknown. Based on the maximum proposed dose of one drop to each eye (0.035 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.

Clinical Studies

Ocular Inflammation and Pain

Bromfenac 0.07% QD for the treatment of postoperative inflammation and reduction of ocular pain was evaluated in two multi-center, randomized, double-masked, parallelgroup and placebo (vehicle)-controlled studies. Patients undergoing cataract surgery self-administered bromfenac 0.07% or vehicle once daily, beginning 1 day prior to surgery, continuing on the morning of surgery and for 14 days after surgery. Complete clearance of ocular inflammation (0 cell and no flare) was assessed on Days 1, 3, 8 and 15 post-surgery using slit lamp biomicroscopy. The pain score was self-reported. The primary efficacy endpoint was the proportion of subjects who had complete clearance of ocular inflammation by day 15. In the intent-to-treat analyses from both assessments, complete clearance at Day 8 and Day 15, bromfenac 0.07% was superior to vehicle as shown in the following table.

Proportion of Subjects with Cleared Ocular Inflammation (0 cells and no flare)

Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI)
Study 1 At Day 8 27/112 (24.1%) 7/108 (6.5%) 17.6 (8.4, 26.8)
At Day 15 51/112 (45.5%) 14/108 (13.0%) 32.5 (21.4, 43.8)
Study 2 At Day 8 33/110 (30.0%) 14/110 (12.7%) 17.3 (6.7, 27.9)
At Day 15 50/110 (45.5%) 30/110 (27.3%) 18.2 (5.7, 30.7)
Proportion of Subjects who Were Pain Free
Study Visit Bromfenac 0.07% Vehicle Difference (%) (Asymptotic 95% CI)
Study 1 At Day 1 91/112 (81.3%) 47/108 (43.5%) 37.7 (25.9, 49.6)
Study 2 At Day 1 84/110 (76.4%) 61/110 (55.5%) 20.9 (8.7, 33.1)

Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

WebMD Daily

Get breaking medical news.

Related Drugs
Health Resources
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations