Postop inflammation & pain drug launched

Durezol 0.05% (difluprednate ophthalmic emulsion; Sirion Therapeutics Inc), a topical corticosteroid to treat postoperative ocular inflammation and pain, is now commercially available, following FDA approval in June 2008.

Durezol has demonstrated, during trials held in Japan and the US, an effective reduction in pain and inflammation amongst subjects suffering inflammation of ≥10 anterior chamber cells, without increasing intraocular pressure (IOP) outside of normal levels. Durezol is administered to the conjunctival sac four times daily for two weeks (beginning 24 hours after surgery) and twice daily for a further week.

Sirion is currently conducting Phase III trials to evaluate Durezol in other ocular conditions, including anterior uveitis. Results of a Phase IIIb trial assessing the efficacy of the drug for the treatment of postoperative ocular inflammation and pain when administered 24 hours prior to surgery have shown that preoperative administration of Durezol is more effective than placebo for reducing ocular pain as early as three or four days after surgery; superiority was maintained until Day 28, regardless of whether Durezol was dosed two or four times daily.