FDA Approves First Topical Rosacea Treatment with Microencapsulated BPO

Today, the Food and Drug Administration approved a proprietary cream formulation of benzoyl peroxide 5% (EPSOLAY) for the treatment of inflammatory lesions of rosacea.

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

“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.”

The approval of the topical treatment was supported by 2 positive phase 3 trials, each lasting 12 weeks, that evaluated the safety and efficacy of EPSOLAY.

The coprimary endpoints of these trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at Week 12

Among the 733 patients with rosacea enrolled in the trials, 50% had clear or almost clear skin following 12 weeks of treatment.

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

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

”Galderma is committed to delivering innovation in dermatology so that healthcare professionals and their patients have the products they need,” said Baldo Scassellati Sforzolini, MD, PhD, 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.”