Galderma announced that the U.S. Food and Drug Administration has approved Differin Epiduo Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5%) for over-the-counter use in individuals aged 12 years and older, marking a major Prescription-to-OTC transition in acne care. This milestone underscores Galderma?s Integrated Dermatology strategy, demonstrating how innovations originating in its Therapeutic Dermatology portfolio can expand and strengthen its Dermatological Skincare offerings. The Prescription-to-OTC switch further highlights the company?s scale and expertise in commercializing dermatology solutions across the full spectrum of acne management.

With Differin Epiduo now available OTC, Galderma is extending access to a dermatologist-recommended, prescription-strength acne treatment to a broader population of acne sufferers, reinforcing its global leadership in acne science. Differin Epiduo combines adapalene, a third-generation retinoid discovered and developed by Galderma to overcome the stability and tolerability limitations of earlier retinoids, with benzoyl peroxide (0.1%/2.5%). This adapalene molecule reflects Galderma?s long-standing leadership in retinoid research, offering an innovation-driven approach that surpasses traditional OTC acne actives.

Together, these dermatologist-trusted ingredients target key biological drivers of acne?clearing clogged pores, eliminating acne-causing bacteria, and reducing inflammation?to help clear existing acne, prevent future breakouts, and improve overall skin tone and texture. The formulation is supported by Galderma?s Simulgel? Gel Base, which stabilizes and evenly distributes both active ingredients while preserving benzoyl peroxide?s efficacy and enhancing tolerability.

This enables a simple, once-daily, one-pump regimen?an ease-of-use level that is essential for building consistent routines and achieving long-term skin clarity. Differin Epiduo?s efficacy has been demonstrated across multiple randomized, controlled Phase 3 studies, where the adapalene/benzoyl peroxide combination consistently outperformed adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory, non-inflammatory, and total acne lesions, as well as Investigator Global Assessment (IGA) success rates. Clinically meaningful improvements in lesion counts were observed as early as Week 1, with antimicrobial activity beginning on Day 1 and up to 70.3% reduction in inflammatory lesions by Week 12.

Long-term data show sustained efficacy, maintaining approximately 65% total lesion reduction through 12 months in a single-arm study, supporting once-daily, ongoing acne control. Efficacy and tolerability were consistent across diverse patient populations and skin tones. Originally approved as a prescription therapy, Epiduo® has been trusted by dermatologists for more than 15 years, with millions of prescriptions written globally.

Its clinical legacy includes more than ten Galderma-sponsored studies involving over 3,200 patients, supplemented by extensive third-party research across a wide range of ages, skin tones, and acne severities. With this Prescription-to-OTC transition, Galderma continues to shape modern acne care by leveraging proprietary science, advancing dermatology, and expanding access to effective treatments. Differin Epiduo will be available OTC at major retailers?including Walmart, Ulta, Target, and Amazon?beginning in summer 2026.

The Differin portfolio also includes cleansers, treatments, and moisturizers designed to support consumers throughout their acne journey. Additional information is available at www.differin.com, along with updates through the Differin community on Instagram, Facebook, and YouTube.