Bromfenac Approved to Treat Cataract-Surgery Inflammation

[Updated June 28, 2005]

Cheryl A. Thompson

BETHESDA, MD, 05 April 2005—Ista Pharmaceuticals Inc. recently announced that it obtained approval to market bromfenac ophthalmic solution, or Xibrom, for the treatment of ocular inflammation in patients who have just had a cataract surgically removed.

The March 24 approval by the Food and Drug Administration (FDA) marks the return of the nonsteroidal antiinflammatory drug (NSAID) to the U.S. market.

The labeling (PDF) for Xibrom states that the ophthalmic solution should be used for no longer than two weeks. Twice-daily application of the solution—one drop into the affected eye—should start 24 hours after cataract surgery and continue for two weeks.

According to the labeling, the use of topical NSAIDs for longer than 14 days after surgery may increase patients' risk of a corneal adverse event that can threaten their sight. That is the only adverse event that the labeling states can be caused by the use of bromfenac ophthalmic solution for longer than is recommended.

Patients with a hypersensitivity to bromfenac, sodium sulfite, benzalkonium chloride, or any other ingredient in the ophthalmic solution must not use it.

Xibrom's labeling states that 2–7 percent of patients who used the product after cataract surgery had such adverse effects as headache and eye irritation, pain, or redness.

Ista announced that it would start selling Xibrom by the end of June, as soon as the company hires more sales representatives and obtains adequate supplies of the product from its manufacturer, Bausch & Lomb Inc.

The ophthalmic product will be available in eyedropper bottles containing 5 mL of 0.09-percent sterile bromfenac solution.

Bromfenac sodium capsules were sold by Wyeth-Ayerst Laboratories from July 1997 to June 1998, when the company withdrew the product because of links to liver disease.

At least 12 people died or needed liver transplants from using the oral bromfenac product known as Duract. According to the company, all but one of these patients had taken the pain reliever for longer than recommended in the product's FDA-approved labeling. A February 1998 effort to curtail the product's use beyond 10 days did not go as well as hoped, and the company withdrew Duract from the market.