Dermatology Duo Sol-Gel and Galderma Granted FDA Approval For Novel Skin Cream

Israel-based dermatology developer, Sol-Gel, announced that one of its proprietary products, EPSOLAY, was granted FDA approval to treat rosacea using unique microencapsulation technology. Sol-Gel granted authorization for skin industry giant, Galderma, to commercialize EPSOLAY in the United States. 

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Slow Release: The Key to Sol-gel’s Skin Cream

The basis of EPSOLAY’s success lies in the microencapsulation technology that Sol-Gel developed to use benzoyl peroxide in topical skin treatments. The benzoyl peroxide is stored in silica-based microcapsules and slowly released over time to the treatment area. 

Sol-Gel’s innovative technology has proven successful throughout all phases of its clinical trials. The most recent Phase 3 clinical trial showed impressive results for patients over a 12-week period. Sol-Gel reported that by the end of the 12-week trial, inflammatory lesions of rosacea were reduced by nearly 70% as opposed to 38-46% in patients who received the vehicle. 

EPSOLAY’s Practical Uses

Rosacea is a common skin ailment affecting over 16 million people worldwide. While rosacea is a chronic condition, it is treatable. Prior treatments for rosacea included various topical ointments, lifestyle management, and diligent sunscreen application. 

Regarding other treatments for rosacea, a dermatologist at Therapeutics Clinical Research in San Diego, Neal D. Bhatia, said, “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.”

Sol-Gel’s Continuing Success with Microencapsulation

Sol-Gel also uses microencapsulation technology in its other novel product, TWYNEO, a topical acne treatment. TWYNEO is also being commercialized in the United States by Galderma and became commercially available on April 14. 

Sol-Gel received patents for its silica-based microencapsulation technology to provide legal protection until 2040. With this patent, Sol-Gel is also conducting research to provide therapy for palmoplantar keratoderma and psoriasis. 

With the help of Galderma, Sol-Gel’s most recent FDA approval of EPSOLAY will help raise the Israeli company higher in the dermatology industry and further its commercial successes in skin treatment.

Author

Reed Slater