Positive top-line results from Epsolay phase III program in papulopustular rosacea

Sol-Gel Technologies, Ltd. announced positive results from its Phase III program evaluating Epsolay (microencapsulated benzoyl peroxide cream, 5%), made with the Company’s proprietary microencapsulation technology, for the treatment of papulopustular rosacea.

In two 12-week clinical studies, SGT 54-01 and SGT 54-02, Epsolay demonstrated statistically significant improvement in both co-primary endpoints of (1) the number of patients achieving “clear” or “almost clear” in the Investigator Global Assessment (IGA) and (2) absolute mean reduction from baseline in inflammatory lesion count. In an additional analysis, Epsolay demonstrated rapid efficacy achieving statistically significant improvements on both co-primary endpoints compared with vehicle as early as Week 2. Epsolay demonstrated a favorable safety and tolerability profile similar to vehicle.