Sol-Gel Technologies’ work to expand the treatment options for patients with the skin condition rosacea has paid off, with the FDA approving a product based on its microencapsulation technology. Galderma will commercialize the topical medicine, Epsolay, in the U.S.
Rosacea is a skin condition characterized by pimplelike breakouts, eye problems and facial redness. The current treatment options include topical antibiotics. Sol-Gel sought to give patients a new option by applying its microencapsulation technology to benzoyl peroxide, thereby controlling the rate of exposure to the active ingredient and mitigating the skin irritation that has limited its use in rosacea to date.
The FDA approved the formulation this week, clearing Sol-Gel’s partner Galderma to start selling the drug in the U.S. Galderma and Sol-Gel secured the approval after a pair of phase 3 clinical trials found the drug was better than placebo at reducing inflammatory lesions and improving disease scale scores.
Neal Bhatia, M.D., a dermatologist at Therapeutics Clinical Research in San Diego, set out what the approval may mean for rosacea patients in the Sol-Gel and Galderma statement to disclose the news.
“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,” Bhatia said.
The clinical data are the product of the use of silica-based microcapsules to encapsulate benzoyl peroxide. Sol-Gel designed the silica-based shell to slowly release the active ingredient. In the clinical trials, between 13% and 25% of subjects on Epsolay suffered mild dryness, itching, scaling and stinging, but moderate cases were seen in fewer than 10% of patients and severe cases were almost nonexistent.