FDA Approval of Epsolay Cream

The US Food and Drug Administration has approved Epsolay cream for the treatment of inflammatory lesions of rosacea, according to Sol-Gel Technologies' announcement. EPSOLAY is 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 (N = 733).

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. With EPSOLAY treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials vs. 38-46% with vehicle.

Nearly 50% of subjects were 'clear' (IGA=0) or 'almost clear' (IGA=1) at 12 weeks vs. 38-46% with placebo. Post-hoc analysis of lesion count and IGA success at Week 2 confirmed a significantly greater treatment effect for EPSOLAY relative to vehicle as early as Week 2. In the open-label extension, 73% of subjects were 'clear' (IGA=0) or 'almost clear' (IGA=1) at 52 weeks (N = 547).

Sol-Gel has granted to Galderma Holding SA ("Galderma") the exclusive rights to commercialize EPSOLAY in the United States. Founded in 1981, Galderma is the world's largest independent dermatology company.

"Having EPSOLAY approved by the FDA is a watershed moment for the 16 million people in the United States suffering from rosacea," stated Alon Seri-Levy, PhD, Chief Executive Officer of Sol-Gel. "Based on the robust clinical data, we believe that EPSOLAY has the potential to change the treatment landscape. We are proud to have Galderma as our partner to launch this drug since Galderma has an unparalleled track record of introducing innovative drugs in the United States' rosacea market," said Dr. Seri-Levy.

Neal D. Bhatia, M.D., dermatologist at Therapeutics Clinical Research in San Diego, California, commented, "There is poor adherence of my patients to current treatments for inflammatory rosacea and I look forward to being able to prescribe EPSOLAY to them, primarily because EPSOLAY has demonstrated outstanding and rapid efficacy results and also because EPSOLAY has been shown to be well-tolerated, both of which are important factors to ensure patients' satisfaction."

"Galderma is committed to delivering innovation in dermatology so that healthcare professionals and their patients have the products they need," said Baldo Scassellati Sforzolini, M.D., Ph.D., Global Head of Research & Development at Galderma. "People with rosacea experience a significant burden of disease with diminished quality of life and the approval of EPSOLAY represents an important advancement for those who are living with rosacea. We are pleased to be able to launch EPSOLAY and look forward to bringing this new treatment option to the United States."