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FDA approves first topical rosacea treatment with microencapsulated BPO

Today, the Food and Drug Administration approved a proprietary formulation of 5% Benzoyl Peroxide Cream (EPSOLAY) for the treatment of inflammatory rosacea lesions.

EPSOLAY is the first and only topical microencapsulated benzoyl peroxide (E-BPO) treatment that relieves blemishes and bumps associated with rosacea, a chronic skin condition known to affect more than 16 million people in the United States.

“The FDA approval of EPSOLAY is a watershed moment for the 16 million people in the United States who suffer from rosacea,” said Alon Seri-Levy, PhD, Sol-Gel’s chief executive officer. “Based on strong clinical data, we believe EPSOLAY has the potential to change the treatment landscape.”

The topical treatment approval was supported by 2 positive Phase 3 trials, each 12 weeks in duration, which evaluated the safety and efficacy of EPSOLAY.

The co-primary endpoints of these trials were the proportion of subjects who successfully completed treatment and the absolute change from baseline in lesion count at week 12.

Of the 733 rosacea patients enrolled in the trials, 50% had clear or nearly clear skin after 12 weeks of treatment.

EPSOLAY cream also reduced inflammatory rosacea lesions by nearly 70% over 12 weeks, and was more effective than vehicle cream on co-primary efficacy endpoints from 4 weeks of treatment in both trials .

Additionally, a post-hoc analysis of lesion count and IGA success at week 2 indicated a significantly greater treatment effect for EPSOLAY compared to vehicle cream, and the open-label extension revealed that 73% of subjects were “clear” (IGA=0) or “almost clear” (IGA=1) at 52 weeks.

“Galderma is committed to innovating in dermatology so that healthcare professionals and their patients have the products they need,” said Baldo Scassellati Sforzolini, MD, PhD, Global Head of Research and Development at Galderma. “People with rosacea experience a heavy disease burden with reduced quality of life and the approval of EPSOLAY represents a significant step forward for those living with rosacea. We are thrilled to be able to launch EPSOLAY and look forward to bringing this new treatment option to the United States. »