NEW YORK (Reuters Health) – Resolution of pain and inflammation after cataract surgery is faster when patients are treated once a day with bromfenac ophthalmic solution, according to the pooled results of four randomized clinical trials reported in the July 18 online issue of Ophthalmology.
“These 4 pooled clinical trials support bromfenac 0.09% as the only ophthalmic NSAID dosed once daily to be clinically safe and effective for reducing and treating ocular inflammation and pain associated with cataract surgery,” the investigators conclude.
In October 2010, the US Food and Drug Administration approved bromfenac 0.09% (Bromday) for this indication with once daily dosing, according to the report.
In the introduction to their paper, Dr. Simon P. Chandler, with ISTA Pharmaceuticals in Irvine, California, and colleagues point out that the management of eye pain and inflammation after cataract surgery has shifted in recent years from postoperative to preoperative dosing with ophthalmic NSAIDs, along with less frequent dosing.
In the current study pooling data from four clinical trials, a total of 872 subjects undergoing cataract surgery with posterior chamber intraocular lens implantation were randomized to receive one drop of either bromfenac 0.09% or placebo instilled in the study eye a day before cataract surgery, on the day of surgery, and for an additional 14 days postop.
The primary efficacy endpoint of cleared inflammation at day 15 was achieved by 51.1% of patients in the bromfenac group and 27.4% in the placebo group (p<0.0001), the researchers found. Similarly, 84% of subjects in the bromfenac group compared with 67% in the placebo group were pain-free on day 1 – the secondary efficacy endpoint.
By day 15, a gain in visual acuity of at least one line was documented in 84% of the bromfenac patients and 66.1% of those given placebo, the data indicate.
Regarding safety, the incidence of adverse events was significantly lower in the bromfenac group (35.1%) than in the placebo group (55.0%), Dr. Chandler and colleagues report.
They conclude, “Bromfenac 0.09% dosed once daily was clinically safe and effective for reducing and treating ocular inflammation and pain associated with cataract surgery.”
The study was sponsored by ISTA Pharmaceuticals, Inc. (Irvine, CA), which also employs four of the six authors.