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Sirion’s Durezol Cleared For Post-Op Ocular Use

This article was originally published in The Pink Sheet Daily

Executive Summary

The first-in-class topical steroid is set to launch in the fourth quarter.

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Sirion submits sNDA for Durezol in uveitis

Sirion's sNDA for use of its topical ophthalmic corticosteroid Durezol to treat endogenous anterior uveitis, an inflammation that is the leading cause of blindness in the U.S., has been accepted by FDA and given an Oct. 24 action date, the company announced March 16. The application is supported by a 90-patient non-inferiority study that compared Durezol (difluprednate) dosed four times daily to Allergan's Pred Forte (prednisolone acetate ophthalmic suspension) dosed eight times a day. Not only was Durezol non-inferior to Pred Forte, it proved numerically superior in "almost every efficacy measure," the firm said, adding that 12.5 percent of patients in the Pred Forte group and no patients in the Durezol arm withdrew due to lack of efficacy. The package also contains data from two Japanese Phase III trials conducted by Senju Pharmaceuticals, from which Sirion licensed U.S. rights for Durezol. Durezol won approval in June 2008 for treatment of postoperative ocular inflammation and pain (1"The Pink Sheet" DAILY, June 24, 2008). Auxilium submits Xiaflex: Auxilium has filed the BLA for its orphan biologic Xiaflex (clostridial collagenase) for treatment of Dupuytren's contracture, a condition that affects the connective tissue beneath the skin in the palm that is currently only treatable with surgery. The submission was based on data for 1,082 treated Dupuytren's contracture patients

Sirion submits sNDA for Durezol in uveitis

Sirion's sNDA for use of its topical ophthalmic corticosteroid Durezol to treat endogenous anterior uveitis, an inflammation that is the leading cause of blindness in the U.S., has been accepted by FDA and given an Oct. 24 action date, the company announced March 16. The application is supported by a 90-patient non-inferiority study that compared Durezol (difluprednate) dosed four times daily to Allergan's Pred Forte (prednisolone acetate ophthalmic suspension) dosed eight times a day. Not only was Durezol non-inferior to Pred Forte, it proved numerically superior in "almost every efficacy measure," the firm said, adding that 12.5 percent of patients in the Pred Forte group and no patients in the Durezol arm withdrew due to lack of efficacy. The package also contains data from two Japanese Phase III trials conducted by Senju Pharmaceuticals, from which Sirion licensed U.S. rights for Durezol. Durezol won approval in June 2008 for treatment of postoperative ocular inflammation and pain (1"The Pink Sheet" DAILY, June 24, 2008). Auxilium submits Xiaflex: Auxilium has filed the BLA for its orphan biologic Xiaflex (clostridial collagenase) for treatment of Dupuytren's contracture, a condition that affects the connective tissue beneath the skin in the palm that is currently only treatable with surgery. The submission was based on data for 1,082 treated Dupuytren's contracture patients

FDA Panel Supports Sirion’s Durezol, But Dosing May Not Provide Market Niche

Twice-daily dosing would provide a convenience advantage for Durezol over other corticosteroids.

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