Long term data for Epsolay confirms safety profile in rosacea.- Sol-Gel Technologies

Sol-Gel Technologies announced positive topline data for its open-label, long-term safety study, evaluating Epsolay (microencapsulated benzoyl peroxide cream 5%) in papulopustular rosacea for a treatment duration up to 52 weeks. The study enrolled 547 subjects, all of whom had completed 12 weeks of treatment with Epsolay or vehicle in the preceding double-blind Phase III studies. Patients continued onto open-label treatment with Epsolay once-daily for up to an additional 40 weeks. The safety population of 535 subjects received Epsolay therapy for an overall period of at least 28 weeks. Of these 535 subjects, 209 subjects completed 52 weeks of treatment with Epsolay, exceeding the sample size requirements previously defined by the FDA for the one-year safety evaluation. Non-cutaneous adverse events were similar in frequency and type to those observed in the preceding Phase III trials. The most common adverse event reported was nasopharyngitis (5.4%). Less than 3% of patients experienced application site adverse events that were considered to be drug-related, and no serious drug-related adverse events were reported. At every study visit, the investigator conducted Local Tolerability and Cutaneous Safety Assessments. At the end of 52 weeks more than 90% of subjects had “none” or “mild” signs or symptoms (burning or stinging, itching, dryness and scaling) and no “severe” tolerability scores were recorded. Although the study was designed to evaluate long-term safety, subjects also continued to undergo evaluation according to the Investigator Global Assessment (IGA) 5-point scale. Of the 209 patients treated with Epsolay for 52 weeks, 73.2% reported a score of 0 (“clear”) or 1 (“almost clear”) at 52 weeks. The company hopes these results will complete the data required to finalize its NDA submission, which is planned for the second quarter of this year.