FDA Approves New Topical Prescription Cream for Rosacea in Adults

The US Food and Drug Administration (FDA) has approved Epsolay, a proprietary cream formulation of benzoyl peroxide, 5% from Sol-Gel Technologies, for the treatment of inflammatory lesions of rosacea in adults. Sol-Gel has granted to Galderma Holding SA the exclusive rights to commercialize the drug in the US.

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 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, accoridng to Sol-Gel. 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 four 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” or “almost clear” 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 or almost clear at 52 weeks.

“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, CEO 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.

”Galderma is committed to delivering innovation in dermatology so that healthcare professionals and their patients have the products they need,” noted Baldo Scassellati Sforzolini, M.D., Ph.D., global head of research and 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.”

Epsolay is covered by granted patents until 2040.