Once daily solution achieves zero-to-trace cell severity

June 11, 2014

Bromfenac ophthalmic solution 0.07% (Pro-Lensa, Bausch + Lomb) used once a day results in zero-to-trace (0–5 cells) cell severity in the anterior chamber following cataract surgery with implantation of a posterior chamber IOL, according to newly published research.

Bromfenac ophthalmic solution 0.07% (Pro-Lensa, Bausch + Lomb) used once a day results in zero-to-trace (0–5 cells) cell severity in the anterior chamber following cataract surgery with implantation of a posterior chamber IOL, according to newly published research. It also performed better than placebo in all outcome measures related to anterior chamber cell severity and inflammation, according to the US researchers, a group including representation from the drug’s manufacturer, Bausch + Lomb. They published their findings in Clinical Ophthalmology.

In two Phase III, double-masked, placebo-controlled, multicentre clinical trials, a total of 440 participants were randomly assigned to treatment with the bromfenac formulation or placebo. Participants were instructed to use once-daily dosing beginning one day before surgery, on the day of surgery and for 14 days after surgery. Follow-up occurred on days 1, 3, 8 and 15.

As early as the third day, researchers found, a significantly greater proportion of participants taking bromfenac had zero to five anterior chamber cells compared with the placebo group. This difference continued at day 8 and day 15, the latter day on which 80.2% of participants in the bromfenac and 47.2% of those in the placebo group met the criterion.

Overall anterior chamber cell scores and the summed ocular inflammation score were significantly lower in the bromfenac group compared with the placebo group at days 3, 8 and 15.

The authors note that, in April, based in part on the results of their clinical trial, the US Food and Drug Administration approved the formulation to treat postoperative inflammation and reduce ocular pain in those who have undergone cataract surgery. "In future clinical assessments, bromfenac 0.07% may be further evaluated in other ocular inflammatory disorders where [nonsteroidal anti-imflammatory drug] use may be potentially beneficial," they conclude.

To access the full study, click here.