Logo

Sol-Gel Technologies and Galderma’ Epsolay Receive the US FDA’s Approval for the Treatment of Inflammatory Lesions of Rosacea in Adults

Share this

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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions