Postoperative pain steroid approved

Article

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.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Recent Videos
Harvey Uy, MD, DPBO, FVRSP, speaks about artificial intelligence (AI) and optical coherence tomography (OCT) at the 2025 European Society of Retina Specialists (EURETINA) Congress.
EURETINA 2025: Boris Stanzel, MD, methotrexate is rocking the European retina landscape
Jeremiah Tao, MD, FACS, discusses his Egyptian Ophthalmological Society keynote, which focused on risk management and avoiding surgical complications in oculofacial surgery
© 2025 MJH Life Sciences

All rights reserved.