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Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)
Date:10/14/2008

ezol (difluprednate ophthalmic emulsion) 0.05% is a topical ophthalmic corticosteroid approved for the treatment of inflammation and pain associated with ocular surgery. Difluprednate, the active ingredient in Durezol, is a difluorinated prednisolone derivative that has potent anti-inflammatory activity. Prior to US approval, the efficacy and safety of difluprednate dosed four times a day in ocular inflammatory diseases had been demonstrated in an extensive preclinical and clinical program in Japan, including two studies in anterior uveitis and one in refractory uveitis. In two US Phase 3 trials evaluating Durezol in patients diagnosed with significant postoperative inflammation (more than 10 anterior chamber cells), Durezol effectively reduced inflammation and pain.

Dosage and Administration

The recommended dosage and administration of Durezol in the treatment of postoperative inflammation and pain is to instill one drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week with tapering based on the response.

Important Safety Information

Like other corticosteroids, Durezol is contraindicated in patients with viral diseases of the cornea and conjunctiva, and those with fungal or mycobacterial infections of the eye or ocular structures. Prolonged use of corticosteroids may increase the hazard of secondary ocular bacterial infections, exacerbate the severity of ocular viral infections, and increase the development of fungal infections of the cornea. It is important to monitor intraocular pressure when using ophthalmic steroids. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acui
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SOURCE Sirion Therapeutics, Inc.
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