Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), announced the Food and Drug Administration (FDA) approval of its drug product, EPSOLAY®, a proprietary cream formulation of benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults.
Rosacea is a chronic facial skin condition of unknown cause. It is characterized by marked involvement of the central face with transient or persistent erythema, telangiectasia, inflammatory papules and pustules, or hyperplasia of the connective tissue.
The benzoyl peroxide in EPSOLAY is encapsulated within silica-based patented microcapsules. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. The approval of EPSOLAY is supported by data from two positive, identical Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of EPSOLAY compared to vehicle in people with inflammatory lesions of rosacea.
Sol-Gel has granted to Galderma Holding SA (“Galderma”) the exclusive rights to commercialize EPSOLAY in the United States. Founded in 1981, Galderma is the world’s largest independent dermatology company.
Alon Seri-Levy, PhD, Chief Executive Officer of Sol-Gel, stated :
Having EPSOLAY approved by the FDA is a watershed moment for the 16 million people in the United States suffering from rosacea. Based on the robust clinical data, we believe that EPSOLAY has the potential to change the treatment landscape. We are proud to have Galderma as our partner to launch this drug since Galderma has an unparalleled track record of introducing innovative drugs in the United States’ rosacea market.
Neal D. Bhatia. M.D., dermatologist at Therapeutics Clinical Research in San Diego, California, commented:
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.
Baldo Scassellati Sforzolini, M.D., Ph.D., Global Head of Research & Development at Galderma, said:
Galderma is committed to delivering innovation in dermatology so that healthcare professionals and their patients have the products they need. People with rosacea experience a significant burden of disease with diminished quality of life and the approval of EPSOLAY represents an important advancement for those who are living with rosacea. We are pleased to be able to launch EPSOLAY and look forward to bringing this new treatment option to the United States.
About Sol-Gel Technologies
Sol-Gel is a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leveraged its proprietary microencapsulation technology platform for TWYNEO®, which is approved for the treatment of acne vulgaris in adults and pediatric patients nine years of age and older; and EPSOLAY, which is approved for the treatment of inflammatory lesions of rosacea in adults. Both drugs are exclusively licensed to Galderma for U.S. commercialization.
The Company’s pipeline also includes early-stage topical drug candidates SGT-210, SGT-310 and SGT-510 under investigation for the treatment of plaque psoriasis and other dermatologic indications.