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An investigational formulation of bromfenac ophthalmic solution has been developed for once-daily administration. Preliminary analyses of data from two phase III clinical trials indicate it is safe and effective for treating ocular pain and inflammation after cataract surgery.
The investigational formulation of the nonsteroidal anti-inflammatory drug (NSAID) contains a higher concentration of bromfenac (0.09%) relative to the product now on the market and is the only ophthalmic NSAID approved for twice-daily administration for treating postcataract surgery pain and inflammation.
The once-daily preparation was investigated in two simultaneously conducted, multicenter, randomized, double-blind studies that randomly assigned more than 500 patients to bromfenac ophthalmic solution or placebo. Treatment began 1 day before cataract surgery and continued for 14 days after the procedure. Clinicians graded the degree of postoperative inflammation at serial follow-up visits and the endpoint of the study to determine the proportion of eyes with no inflammation at the end of postoperative day 14.
An initial analysis showed a statistically significant difference favoring bromfenac sodium over placebo in that rigorous endpoint.
William Trattler, MD, was a clinical investigator in one of the phase III trials, and his center led the study with the highest patient enrollment.
Dr. Trattler is in private practice at Center for Eye Care Excellence, Miami, and volunteer assistant professor, Bascom Palmer Eye Institute, University of Miami.
Carlos Buznego, MD, another investigator at Center for Excellence in Eye Care, Miami, said he was a bit skeptical that a once-a-day NSAID formulation could reduce and eliminate postoperative inflammation by itself.
"I was even more surprised when the study protocol was designed to look for resolution of inflammation by postoperative day 14," he said. "However, I was quite impressed that a substantial number of my patients had such a good response and such a quick one."
Based on the preliminary results of the studies and pending final analyses, ISTA Pharmaceuticals plans to file a supplemental new drug application with the FDA in the second half of this year for the bromfenac once-daily formulation for the treatment of ocular pain and inflammation associated with cataract surgery.
Approval in near future
"One would expect that the data would be powerful enough to allow for approval of this medication in the near future," Dr. Trattler noted. "Once approved, this medication would provide doctors and patients with an additional treatment option, and this could prove to be very useful because of the decreased dosing requirement compared with other medications."
ISTA President and Chief Executive Officer Vicente Anido Jr., PhD, said that these data demonstrate the success of the company's efforts to improve its flagship product.
"The once-daily formulation will provide the most potent and conveniently dosed ophthalmic NSAID to patients undergoing cataract surgery," he said. "As studies show time and again, less-frequent dosing improves patient compliance, and we believe patients will benefit significantly should the once-daily bromfenac sodium ophthalmic solution receive FDA approval."