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Prolensa

"A study in mice reveals an elegant circuit within the developing visual system that helps dictate how the eyes connect to the brain. The research, funded by the National Institutes of Health, has implications for treating amblyopia, a vision diso"...

Prolensa

CLINICAL PHARMACOLOGY

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.

Pharmacokinetics

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.

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