Biofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development of Ameluz® Photodynamic Therapy for moderate to severe Acne Vulgaris

Core Insights - Biofrontera Inc. announced positive results from its Phase 2b clinical trial for Ameluz PDT in treating moderate to severe acne vulgaris, indicating a significant reduction in inflammatory lesions compared to the vehicle group [1][4][5] Clinical Study Details - The Phase 2b study was a multicenter, randomized, double-blind trial comparing Ameluz with a vehicle gel, utilizing two incubation times (1 hour and 3 hours) before treatment with the BF-RhodoLED lamp [2] - The study's co-primary endpoints included the relative reduction in inflammatory lesion counts and an improvement of at least two grades on a modified Investigator Global Assessment (mIGA) scale [3] Clinical Results - The 3-hour incubation regimen showed a 57.97% reduction in inflammatory lesions for the Ameluz group, compared to a 36.51% reduction in the vehicle group [5] - For the mIGA analysis, 25% of Ameluz-treated patients met the co-primary endpoint, while 21.4% of vehicle patients achieved the same outcome [5] - Absolute lesion count reductions were also significant, with Ameluz showing reductions of 19.7, 23.1, and 42.7 for inflammatory, non-inflammatory, and total lesions, respectively, compared to 15.4, 16.5, and 31.9 for the vehicle [6] Safety and Patient Satisfaction - Ameluz PDT demonstrated a favorable safety profile, with mild to moderate treatment-related adverse events such as burning sensation and pruritus [7] - Average pain scores during the 3-hour incubation were modest, ranging from 3.4 to 3.8 for Ameluz and 2.0 to 2.1 for the vehicle on an 11-point scale [8] - High patient satisfaction was reported, with 85.7% of patients stating they would choose PDT again and 71.4% rating their esthetic outcome as "good" or "very good" [8] Market Opportunity - Acne vulgaris is a prevalent dermatologic condition in the US, affecting millions and representing a significant treatment market, with potential for permanent scarring and psychosocial impacts [9] - Current treatment options often involve long-term daily therapies or systemic treatments with safety concerns, driving interest in alternative approaches like photodynamic therapy [10][11] Future Plans - The company plans to present the Phase 2b data to the U.S. Food and Drug Administration (FDA) in Q3 2026 to discuss next steps for developing Ameluz PDT for acne vulgaris [13]