Sol-Gel expects top-line results for Epsolay in 2019

Sol-Gel Technologies announced that it has completed enrollment of half of the patients in its pivotal Phase III clinical trials of Epsolay in subjects with papulopustular rosacea, a chronic, inflammatory skin condition that most often affects the face. Epsolay is a once-daily topical cream containing encapsulated benzoyl peroxide, 5%, using Sol-Gel’s proprietary microencapsulation technology. The pivotal Phase III clinical program is being conducted in accordance with Special Protocol Assessmentagreements with the U.S. Food and Drug Administration and consists of two randomized, multi-center, double-blind, vehicle-controlled clinical trials at 50 sites in the United States. Each pivotal trial is planned to enroll 350 subjects in a 2:1 ratio of Epsolay in comparison to its vehicle, with a power of greater than 99%. The primary efficacy endpoints for both trials are success in Investigator Global Assessment, defined as a two-grade reduction in IGA on a scale of 0 to 4 with “clear” or “almost clear”at week 12, and a reduction in mean inflammatory lesion count at week 12. “The progress we have made with patient enrollment in these trials and the high interest expressed by both the patients and physicians highlights the unmet medical need for a new safe and efficacious rosacea treatment,” said Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Our goal is to advance Epsolay as a potential treatment option for papulopustular
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