Data integrated from two phase III clinical trials demonstrate that a new, once-daily formulation of bromfenac ophthalmic solution higher in concentration than the commercially available 0.09% formulation (Xibrom, ISTA Pharmaceuticals) is safe, effective, and well-tolerated for the prevention and treatment of inflammation and pain associated with ocular surgery. Increased patient adherence to therapy and improved outcomes are two potential benefits.
Miami-A new, once-daily formulation of bromfenac ophthalmic solution at a higher concentration than the commericially available 0.09% formulation (Xibrom, ISTA Pharmaceuticals) is safe and effective for the prevention and treatment of inflammation and pain associated with ocular surgery, according to William B. Trattler, MD.
Dr. Trattler and his colleagues integrated the data from two phase III clinical trials of the new formulation, developed by the company, to determine its safety and efficacy for the treatment of ocular inflammation and pain in patients who had undergone cataract extraction with posterior chamber IOL implantation. He is director of cornea for the Center for Excellence in Eye Care, Miami, and volunteer assistant professor, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami.
The currently available formulation of bromfenac ophthalmic solution, administered twice daily, was approved by the FDA in March 2005 for the treatment of postoperative ocular inflammation and in January 2006 for the treatment of postoperative ocular pain. A once-daily dosing option potentially could increase patient adherence to the treatment regimen, thereby enhancing clinical outcomes, according to the manufacturer.
The new, higher concentration of bromfenac was found to be statistically superior to placebo both in clearance of ocular inflammation and in absence of ocular pain following cataract surgery, he said.
Pain was managed much better by bromfenac than placebo, especially in the early postoperative period, according to the company.
The safety profile of the new formulation was consistent with the currently marketed bromfenac formulation, according to Dr. Trattler.
"We achieved very good results with this new formulation, both in terms of managing inflammation and reducing pain after cataract surgery," said Dr. Trattler.
The results from the studies did not demonstrate that the once-daily product provided superior control of inflammation and pain compared with the current twice-daily regimen, nor was the new formulation compared against other available topical non-steroidal drops, he added.
The higher concentration and the commercially available concentration of bromfenac ophthalmic solution were demonstrated to be clinically equivalent in a subsequent trial reported by the manufacturer.
"Topical non-steroidal anti-inflammatory agents have always played a very important and valuable role with cataract surgery," Dr. Trattler explained. "As such, it is exciting to see the development of new treatments that may allow for reduced dosing while still providing effective treatment of pain and postoperative inflammation.
"That's the goal of this new formulation. It was very effective, it was well-tolerated, and a once-a-day formulation could potentially help with patient compliance," he said.
"However, the key future finding would be to determine whether the [new formulation of] bromfenac...provides superior results than the currently available formulation," he concluded.