Sirion introduces topical ophthalmic pain drug

Durezol, which was approved by the FDA in June 2008, is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery.

Susan Benton, senior vice president of sales and marketing for Sirion Therapeutics, said: “Because Durezol is the first and only steroid with an approval for both inflammation and pain, it is the first innovation in the strong steroid class in over 35 years. We believe Durezol will give patients and physicians a more comprehensive option for post-operative care.”

Sirion also announced the completion of two Phase IIIb studies that evaluated Durezol for the management of post-operative inflammation in which treatment was initiated one day prior to surgery.

The multicenter, randomized, double-masked, placebo-controlled, parallel-group trials were conducted in 245 patients undergoing unilateral ocular surgery. In the first study of 124 patients, Durezol or placebo was dosed four times daily (QID), while in the second study, 121 patients received Durezol or placebo twice daily (BID).

A significantly greater percentage of patients receiving Durezol QID or BID achieved a clinical response (defined as less than or equal to five anterior chamber cells and no flare) by day 14. Approximately 81.3% of the Durezol treated patients in the QID group had a clinical response versus 25% of the placebo QID group (P<0.0001); 74.7% of the Durezol BID patients had a clinical response versus 42.5% of patients in the placebo BID group (P<0.001). Both Durezol groups maintained superiority over the placebo groups through day 28, demonstrating that efficacy was definitive and did not decrease or reverse over time.