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Sol-Gel Technologies Says FDA Approves EPSOLAY For Inflammatory Lesions Of Rosacea

Dermatology company Sol-Gel Technologies, Ltd. (SLGL) announced Monday the U.S. Food and Drug Administration (FDA) approval of its drug product, EPSOLAY, a proprietary cream formulation of benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults.

The benzoyl peroxide in EPSOLAY is encapsulated within silica-based patented microcapsules. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile.

The approval of EPSOLAY is supported by data from two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of EPSOLAY compared to vehicle in people with inflammatory lesions of rosacea.

The coprimary endpoints in both trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at Week 12. EPSOLAY was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both trials.

Sol-Gel has granted to Swiss dermatology company Galderma Holding SA the exclusive rights to commercialize EPSOLAY in the United States.

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