FDA approves Epsolay cream for rosacea

The FDA has approved Epsolay cream for the treatment of inflammatory lesions of rosacea, Sol-Gel Technologies announced in a press release.

Epsolay, a cream formulation of benzoyl peroxide 5% encapsulated within silica-based microcapsules, is designed to slowly release the drug over time.

“Having Epsolay approved by the FDA is a watershed moment for the 16 million people in the United States suffering from rosacea,” Sol-Gel CEO Alon Seri-Levy, PhD, said in the release. “Based on the robust clinical data, we believe that Epsolay has the potential to change the treatment landscape.”

The approval is based on data from two phase 3 trials in which patients treated with Epsolay had a nearly 70% reduction in rosacea lesions compared with 38% to 46% of those treated with vehicle.

Exclusive commercialization rights for Epsolay have been granted to Galderma Holding SA.

“Galderma is committed to delivering innovation in dermatology so that health care professionals and their patients have the products they need,” Baldo Scassellati Sforzolini, MD, PhD, global head of research and development at Galderma, said in the release. “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.”