Epsolay® (benzoyl peroxide) cream is now available 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 of Epsolay 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.

The coprimary endpoints of both studies were the proportion of patients with treatment success at week 12, defined as an Investigator Global Assessment 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.

Epsolay was found to be more effective than vehicle cream on the coprimary efficacy endpoints starting from 4 weeks of treatment in both trials. The most common adverse reactions reported with treatment were application site reactions including pain, erythema, pruritus and edema.

“Until now, [benzoyl peroxide] has never been indicated to treat rosacea in part due to its poor tolerability for sensitive skin,” said Ted Lain, MD, Executive Director, Austin Institute for Clinical Research and principal investigator for the Epsolay clinical trials. “Epsolay cream helps overcome tolerability issues via its patented microencapsulation technology which controls the gradual release of [benzoyl peroxide] onto the skin.”

Epsolay is supplied in a 30 gram pump with each gram containing 50mg of benzoyl peroxide. Galderma is offering a copay savings card for eligible patients.

References

  1. Galderma launches Epsolay® cream, a medical advance to treat bumps and blemishes of rosacea. News release. Galderma. Accessed June 2, 2022. https://www.multivu.com/players/uk/9055151-galderma-launches-epsolay-cream/
  2. Epsolay. Package insert. Galderma; 2022. Accessed June 2, 2022. https://www.galderma.com/us/sites/default/files/2022-03/Epsolay_PI.pdf