Postoperative pain steroid approved

June 30, 2008

Durezol (difluprednate ophthalmic emulsion; Sirion Therapeutics) 0.05%, a topical steroid, has received US Food and Drug Administration (FDA) approval for the treatment of postoperative ocular inflammation and pain.

Durezol (difluprednate ophthalmic emulsion; Sirion Therapeutics) 0.05%, a topical steroid, has received US Food and Drug Administration (FDA) approval for the treatment of postoperative ocular inflammation and pain.

Michael Korenfeld, MD of Washington University, St Louis, US and colleagues conducted two Phase III trials. The multicentre studies evaluated subjects with significant postoperative inflammation (n=438) who were treated with Durezol or a placebo. Subjects were dosed twice (BID) and four times (QID) daily, beginning 24 hours postoperatively and continuing for four weeks.

One week postoperatively, a slightly higher number of patients were completely free of pain and inflammation on the QID regime compared with the BID regime. Two weeks after surgery, Durezol was found to reduce anterior chamber cells by 86% on the BID regimen and 87% on the QID regimen. Following treatment, 3% of subjects in each Durezol dosing group and 1% of patients treated with placebo had a rise in intraocular pressure (IOP) ≥21 mmHg, although mean IOP remained within the normal range for each group throughout the study.

Sirion plans to launch Durezol, the first steroid indicated for postoperative ocular pain, on the market before the end of this year.