Biofrontera Inc. Announces New Patent Protection on Ameluz® until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris

Core Viewpoint - Biofrontera Inc. has received patent approval for an updated formulation of Ameluz, extending protection until December 2043, and has successfully enrolled the final patient in a Phase 2b clinical trial for treating moderate to severe acne vulgaris [1][5][8]. Company Summary - Biofrontera Inc. specializes in photodynamic therapy (PDT) for dermatological conditions and commercializes Ameluz in combination with the RhodoLED lamp series [9]. - The company aims to expand the indications for Ameluz beyond its current approval for mild to moderate actinic keratosis [5]. - The successful enrollment of 120 patients in the Phase 2b trial marks a significant milestone for the company [3][5]. Industry Summary - The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3% [4][8]. - Acne vulgaris affects an estimated 50 million people annually in the U.S., with about 40% of adults experiencing the condition [6][8]. - Current treatment options for moderate to severe inflammatory acne include topical therapies, oral antibiotics, and isotretinoin, which may have serious side effects, highlighting the need for effective alternatives [7][8].