FDA Approves Epsolay (benzoyl peroxide) Cream for the Treatment of Rosacea
NESS ZIONA, Israel and ZUG, Switzerland, April 25, 2022 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, announced today 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.
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 (N = 733). The coprimary endpoints in both trials were the proportion of subjects with treatment success and the absolute change from baseline in lesion counts at Week 12. Epsolay was more effective than vehicle cream on the co-primary efficacy endpoints starting from 4 weeks of treatment in both trials. With Epsolay treatment, inflammatory lesions of rosacea were reduced by nearly 70% by the end of both 12-week trials vs. 38-46% with vehicle. Nearly 50% of subjects were ‘clear’ (IGA=0) or ‘almost clear’ (IGA=1) at 12 weeks vs. 38-46% with placebo. Post-hoc analysis of lesion count and IGA success at Week 2 confirmed a significantly greater treatment effect for Epsolay relative to vehicle as early as Week 2. In the open-label extension, 73% of subjects were ‘clear’ (IGA=0) or ‘almost clear’ (IGA=1) at 52 weeks (N = 547).
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.
“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. 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,” said Dr. Seri-Levy.
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.”
”Galderma is committed to delivering innovation in dermatology so that healthcare professionals and their patients have the products they need,” said Baldo Scassellati Sforzolini, M.D., Ph.D., Global Head of Research & Development at Galderma. “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.”
Epsolay is a topical cream containing benzoyl peroxide, 5%, for the treatment of inflammatory lesions of rosacea in adults. Epsolay utilizes a proprietary technology to encapsulate benzoyl peroxide within silica-based microcapsules to create a barrier between the medication and the skin. The silica-based shell is designed to slowly release benzoyl peroxide over time to provide a favorable efficacy and safety profile. Epsolay is covered by granted patents until 2040.
IMPORTANT SAFETY INFORMATION
Epsolay is contraindicated in patients with a history of a serious hypersensitivity reactions to benzoyl peroxide or any component of the formulation in Epsolay.
WARNINGS AND PRECAUTIONS
- Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with the use of benzoyl peroxide products. (5.1)
- Skin irritation/contact dermatitis: Erythema, scaling, dryness, stinging/burning, irritation and allergic contact dermatitis may occur with use of Epsolay and may necessitate discontinuation.
- Photosensitivity: Avoid or minimize exposure to natural or artificial sunlight and use sun protection measures while using Epsolay.
- The most common adverse reactions were application site reactions: pain (2%), erythema (2%), pruritis (1%) and edema (1%).
To report SUSPECTED ADVERSE REACTIONS, contact Sol-Gel Technologies Inc. at [1-866-SGT-AERS (748-4377)] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Inflammatory Lesions of Rosacea
Rosacea is a chronic and recurrent skin condition that can potentially worsen over time. More than 82% of people with rosacea feel that their condition is uncontrolled and rosacea can deeply affect self-esteem and mental health.
Inflammatory lesions of rosacea is a chronic and recurrent skin disorder that affects millions of Americans. The condition is especially common in fair-skinned people of Celtic and Northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses, the redness becomes more persistent, blood vessels become visible, and inflammatory lesions often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.
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.
For additional information, please visit www.sol-gel.com.
Galderma is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story.
For additional information, please visit www.galderma.com/us.
Source: Sol-Gel Technologies Ltd.
Posted: April 2022