FDA Gives Thumbs Up to Eye Drug

July 1, 2008

The FDA has approved Sirion Therapeutics’ Durezol, a topical steroid used to treat postoperative ocular inflammation and pain.

The Durezol (difluprednate ophthalmic emulsion) 0.05 percent approval came after a six-month priority review. Sirion acquired U.S. development rights for the product in 2006 from Japanese drugmaker Senju Pharmaceutical.

Durezol was evaluated in two Phase III trials that included 438 subjects who had significant inflammation the day after ocular surgery, according to Sirion. Subjects received the drug two or four times daily or placebo over a four-week period.

Data from the trials showed Durezol rapidly reduced inflammation and pain compared with placebo, the company said. Patients given the drug four times a day were slightly more likely to be free from inflammation and pain after one week. 

Sirion plans to make Durezol, which is its first FDA-approved product, commercially available later this year. The drug also is being studied to treat such other ocular inflammatory diseases as anterior uveitis.