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Los Angeles—Results from the Xibrom First Experience (XFE) trial show that the new twice-a-day nonsteroidal anti-inflammatory drug (NSAID) is being well received by cataract surgeons and their patients alike, said David F. Chang, MD.
Bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals) was approved in March 2005 for the reduction of ocular inflammation after cataract surgery and was launched in June.
However, more than 400 high-volume cataract surgeons were contacted prior to the launch about participating in an "early experience trial," and more than 90% agreed to use the new agent and report their impressions.
"[Bromfenac] . . . offers potent anti-inflammatory activity for controlling pain and inflammation and also has two features that distinguish it from previously available NSAIDs," said Dr. Chang, clinical professor of ophthalmology, University of California, San Francisco. "Bromfenac is the only topical NSAID to provide the convenience of twice-daily dosing, and it seems to be associated with less incidence of stinging upon instillation.
"Its safety and efficacy were established in placebo-controlled, FDA-monitored clinical trials," Dr. Chang continued. "However, in the absence of head-to-head comparison studies, cataract surgeons are still interested in learning how well bromfenac performs relative to existing NSAIDs before they change their prescribing patterns.
"The XFE study is an opinion survey, not a prospective clinical trial, and the judgments of the participants are based on a very small sample size," he added. "However, the respondents were all experienced cataract surgeons who were very familiar with the clinical performance of existing NSAIDs. Their positive feedback may give other clinicians greater confidence in trying bromfenac."
The physician participants were asked to rate how well bromfenac performed in the following areas:
Responses were chosen from one of the following four descriptors: exceeded expectations (very satisfied); met expectations (satisfied); met some expectations (dissatisfied); or did not meet expectations (very dissatisfied).
"If a clinician is already happy with ketorolac or diclofenac, it is important that any new NSAID perform at least as well," Dr. Chang said. "The fact that bromfenac so often exceeded physician expectations is a promising indicator that surgeons may eventually find it to be superior to their current preferred NSAID."
Based on their first experiences, 40% of the surgeons indicated they may replace other NSAIDs in their practices with bromfenac, while 57% agreed that they were satisfied and would continue using the new NSAID.