The U.S. Food and Drug Administration (FDA) has approved Epsolay, a 5% encapsulated benzoyl peroxide (E-BPO) cream developed by Sol-Gel Technologies and Galderma, for the treatment of inflammatory lesions of rosacea (papulopustular rosacea or PPR) in adult patients. This approval marks a significant advancement in rosacea treatment, offering a new option for the estimated 16 million Americans suffering from the condition.
The approval was based on data from two identical Phase 3 randomized, double-blind, multicenter, 12-week clinical trials. These trials evaluated the safety and efficacy of Epsolay compared to a vehicle cream in 733 patients with inflammatory lesions of rosacea. The co-primary endpoints were the proportion of patients with treatment success and the absolute change from baseline in lesion counts at week 12.
Clinical Trial Results
The trials demonstrated that Epsolay was significantly more effective than the vehicle cream in achieving both co-primary endpoints, with improvements observed as early as 4 weeks. By the end of the 12-week trials, Epsolay reduced inflammatory lesions by nearly 70%, compared to a 38% to 46% reduction with the vehicle cream. Furthermore, almost 50% of patients treated with Epsolay achieved an Investigator's Global Assessment (IGA) score of 0 or 1 at 12 weeks, indicating clear or almost clear skin, compared to 38%-46% with placebo.
A post-hoc analysis of lesion count and IGA success at week 2 confirmed a significantly greater treatment effect for Epsolay relative to the vehicle. In an open-label extension study, 73% of patients achieved an IGA score of 0/1 at 52 weeks.
Mechanism of Action and Tolerability
Epsolay utilizes Sol-Gel's patented microencapsulation technology, which encases the benzoyl peroxide within silica-based microcapsules. This design allows for a slow release of benzoyl peroxide over time, aiming to reduce the risk of skin irritation commonly associated with benzoyl peroxide treatments.
According to the manufacturers, the most common adverse events reported were application site reactions, including pain (2%), erythema (2%), pruritus (1%), and edema (1%).
Expert Commentary
"Having Epsolay approved by the FDA is a watershed moment for the 16 million people in the United States suffering from rosacea," stated Alon Seri-Levy, PhD, Chief Executive Officer of Sol-Gel. "Based on the robust clinical data, we believe that Epsolay has the potential to change the treatment landscape."
Neal D. Bhatia, MD, a dermatologist at Therapeutics Clinical Research in San Diego, California, noted, "There is poor adherence of my patients to current treatments for inflammatory rosacea and I look forward to being able to prescribe Epsolay to them, primarily because Epsolay has demonstrated outstanding and rapid efficacy results and also because Epsolay has been shown to be well-tolerated, both of which are important factors to ensure patients' satisfaction."
