Sol-Gel’s and Galderma’s Epsolay Gets FDA Nod for Rosacea

The FDA has approved Sol-Gel’s and Galderma’s topical drug Epsolay (benzoyl peroxide 5 percent) to treat adult patients with rosacea-associated inflammatory skin lesions.

The cream encapsulates the benzoyl peroxide within silica-based patented microcapsules that are designed to slowly release the active ingredient over time.

The approval was supported by results from two late-stage clinical trials in which participants given the treatment showed an improvement in lesion counts by week 12. The cream reduced inflammatory lesions by nearly 70 percent, the companies said.

Sol-Gel, which is headquartered in Israel, has granted Switzerland-based Galderma exclusive rights to commercialize Epsolay in the U.S.