Sol-Gel (Nasdaq:SLGL) and Galderma have announced that it has won FDA approval for Epsolay cream, a proprietary topical formulation of benzoyl peroxide, 5%, for treating inflammatory rosacea lesions.
Rosacea is a common condition, but experts have struggled to estimate its global prevalence. A 2018 estimate in the British Journal of Dermatology concluded that the condition affects between 5% and 46% of the adult population.
Galderma and Sol-Gel report that Epsolay Cream is the only topical treatment shown to relieve bumps and blemishes associated with rosacea.
Galderma, the world’s largest independent dermatology company, will commercialize the cream in the U.S.
First prepared in 1958, benzoyl peroxide is widely used as an over-the-counter topical acne treatment.
Epsolay cream is encapsulated within patented silica shells that steadily release benzoyl peroxide to optimize efficacy and tolerability. In particular, benzoyl peroxide can cause skin irritation in patients with sensitive skin.
Sol-Gel reports that 82% of rosacea patients feel their condition is uncontrolled.
In clinical studies, Epsolay decreased bumps and blemishes associated with rosacea by almost 70% in 12 weeks.
Sol-Gel reports that almost half of rosacea patients receiving the cream had clear or nearly clear skin after 12 weeks of receiving the cream treatment.
Filed Under: Dermatology