Sirion Therapeutics, Inc. has announced the result of a clinical comparison study on the FDA approved drug Durezol(TM) and Pred Forte(R). The investigational drug aimed for the potentially blinding eye diseases. They are likely to be used for treatment of problems like inflammation and pain associated with ocular surgery. The results will be presented at the upcoming ophthalmology meetings: At the American Uveitis Society's annual invitational meeting.
The randomized, multicenter, double-masked trial included 90 subjects with endogenous anterior uveitis having greater than 10 cells and a flare score of greater than or equal to 2 in the anterior chamber (AC). In the study, Durezol administered QID was as effective as Pred Forte dosed eight times a day in treating uveitis.
Durezol was also safe and well tolerated. The primary endpoint of the uveitis study was the difference from baseline in AC cell grades between the Durezol and Pred Forte groups. At Day 14, the Durezol group achieved a mean cell grade reduction of 2.1, compared to 1.9 in the Pred Forte group, confirming the noninferiority of Durezol dosed QID to Pred Forte dosed eight times a day.
Uveitis is responsible for an estimated 30,000 new cases of legal blindness each year in the US and up to 15% of all cases of blindness. The most common form of the condition is anterior uveitis, associated primarily with inflammation of the iris.
If left untreated, uveitis can cause debilitating pain and photophobia as well as permanent damage and vision loss due to the development of glaucoma, cataract or retinal edema. The efficacy and safety data is from an extensive clinical program conducted outside of the US by Laboratoires Thea of France, with which Sirion Therapeutics has an exclusive licensing agreement for the US rights to develop and market ganciclovir ophthalmic gel, available in Europe for the treatment of ocular viral infections for more than 10 years.
Durezol (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. Durezol is not approved for the treatment of uveitis.