Sol-Gel Technologies and Galderma’ Epsolay Receive the US FDA’s Approval for the Treatment of Inflammatory Lesions of Rosacea in Adults
Shots:
- The approval was based on the two P-III trials to evaluate Epsolay vs vehicle cream in patients with inflammatory lesions of rosacea
- The coprimary EPs in both trials were the proportion of patients with treatment success & the absolute change from baseline in lesion counts @12wk. the therapy was effective @ 4wks. of treatment, 70% vs 38-46% reduction in inflammatory lesions of rosacea & 50% were clear or almost clear over 38-46% with PBO @12wk. Post-hoc analysis of lesion count & IGA success demonstrated a greater treatment effect as early as 2wk.
- In the OLE study, 73% were clear or almost clear @52wks. Epsolay (benzoyl peroxide, cream 5%) uses microencapsulation technology & is patent protected until 2040
Ref: Sol-Gel | Image: Sol-Gel
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