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Prescription treatment Epsolay has FDA approval.
June 2, 2022
By: Christine Esposito
Editor-in-Chief
Skin health expert Galderma has expanded its prescription skin treatment stable for roasacea, a skin condition that impacts more than 16 million people in the US. The company today announced the availability of Epsolay (benzoyl peroxide) Cream, 5% in the US following approval by the US Food and Drug Administration (FDA) on April 22, 2022. It is the first and only microencapsulated benzoyl peroxide (E-BPO) topical treatment proven to relieve the bumps and blemishes of rosacea and provides rapid, significant and sustained relief, said Galderma.
Rosacea is a chronic and recurrent skin condition that can worsen over time. More than 82% of people feel their rosacea is uncontrolled, and less than 50% are satisfied with their current prescription treatments. In fact, rosacea can be so challenging to manage that 55% of people with the skin condition and a high disease burden, reported a willingness to give up one year or more of their life to cure their symptoms. “Through our decades-long heritage in dermatology and skin science, Galderma is committed to bringing cutting-edge innovation to patients with rosacea and the healthcare professionals who treat them,” said Anthony Pansy, VP and GM of the US prescription business at Galderma.
Source: Galderma
In clinical trials, treatment with EPSOLAY Cream reduced bumps and blemishes of rosacea by up to 43.7% in two weeks and by nearly 70% in 12 weeks. Eposlay Cream gradually releases benzoyl peroxide onto the skin, making it suitable and well-tolerated for the sensitive skin of rosacea patients. In a 52 week long-term safety study, side effects which occurred in participants using Epsolay Cream were mostly mild in nature.11 In 12 week trials, almost 50% of participants who used Epsolay Cream in the trial were clear or almost clear by 12 weeks.
“Until now, BPO has never been indicated to treat rosacea in part due to its poor tolerability for sensitive skin. Epsolay Cream helps overcome tolerability issues via its patented microencapsulation technology which controls the gradual release of BPO onto the skin,” said Ted Lain, MD, executive director, Austin Institute for Clinical Research and principal investigator for the Epsolay Cream clinical trials. “Epsolay Cream showed great efficacy and tolerability in the pivotal trials, as evidenced by high patient satisfaction and compliance.”
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