The Food and Drug Administration (FDA) has approved Epsolay® (benzoyl peroxide) cream for the treatment of inflammatory lesions of rosacea in adults.
Epsolay is a topical cream that utilizes a patented technology process to encapsulate benzoyl peroxide 5% within silica-based microcapsules. Once applied, the medication slowly migrates from the microcapsules to deliver an effective dose of benzoyl peroxide to the skin, while also reducing skin irritation.
The approval was based on data from 2 identical, double-blind, phase 3 trials (ClinicalTrials.gov Identifier: Trial 1 [NCT03448939] and Trial 2 [NCT03564119]) that compared the efficacy and safety of Epsolay to vehicle in 733 patients with moderate to severe papulopustular rosacea. Patients were randomly assigned to receive either Epsolay or vehicle once daily for 12 weeks.
The coprimary endpoints were the proportion of patients with treatment success at week 12, defined as an Investigator Global Assessment (IGA) score of 0 (“clear”) or 1 (“almost clear”) with at least a 2-grade reduction from baseline, and the absolute change in inflammatory lesion counts at week 12.
Results showed that 47.4% and 49.2% of patients in Trials 1 and 2, respectively, reported IGA treatment success with Epsolay compared with 20.7% and 28.2% of patients treated with vehicle. At week 12, inflammatory lesions of rosacea were reduced by 68.2% (Trial 1) and 69.4% (Trial 2) with Epsolay vs 38.3% and 46.0%, respectively, with vehicle. A significantly greater treatment effect for Epsolay relative to vehicle was observed as early as week 2. In the open-label extension phase (N=547), 73% of Epsolay-treated patients had achieved IGA treatment success at week 52.
The most common side effects reported were application site reactions including pain, erythema, pruritus and edema.
Epsolay will be made available by Galderma in the US.
- Sol-Gel Technologies and Galderma announce FDA approval of Epsolay®. News release. Sol-Gel Technologies Ltd. Accessed April 25, 2022. https://www.globenewswire.com/news-release/2022/04/25/2427977/0/en/Sol-Gel-Technologies-and-Galderma-Announce-FDA-Approval-of-EPSOLAY.html
- Epsolay. Package insert. Sol-Gel Technologies Ltd; 2022. Accessed April 25, 2022. https://ml.globenewswire.com/Resource/Download/c90c6cab-73f1-4f49-a08a-83bbf291a415