Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT

Core Viewpoint - Biofrontera Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for Ameluz-PDT, seeking approval for the treatment of superficial basal cell carcinoma (sBCC) [1][9]. Submission Details - The submission includes comprehensive efficacy data from a Phase 3 study and a one-year follow-up, along with an integrated safety assessment from U.S. and European clinical studies [2]. - The filing aims to expand the Ameluz label to include sBCC treatment using BF-RhodoLED or RhodoLED XL red light lamps [2]. Study Overview - A double-blind, randomized, placebo-controlled Phase 3 study evaluated Ameluz-PDT in 187 patients with confirmed sBCC [3]. - Participants received one or two cycles of PDT treatments, with a second cycle possible at three months if needed [3]. Efficacy Results - The primary endpoint showed a 65.5% clearance rate in the Ameluz-PDT group compared to 4.8% in the placebo group, with a highly significant statistical difference (p<0.0001) [4]. - Key secondary endpoints indicated even higher efficacy: - Complete histological clearance in 75.9% of Ameluz patients vs. 19.0% in placebo [5]. - Complete clinical clearance in 83.4% of Ameluz patients vs. 21.4% in placebo [5]. - Total clearance of all sBCC lesions in 64.1% of Ameluz patients vs. 4.8% in placebo [5]. Patient Outcomes - Patient-reported outcomes showed 85.5% rated their treatment satisfaction and aesthetic outcome with Ameluz-PDT as very good or good [6]. - One-year follow-up data indicated low recurrence rates and excellent long-term cosmetic outcomes [6]. Industry Context - BCC is the most common skin cancer in the U.S., with over 3 million cases diagnosed annually [9]. - Actinic keratosis (AK), a precursor to skin cancer, affects approximately 58 million people in the U.S., with 13 million AK treatments performed in 2020 [8]. Company Perspective - The CEO of Biofrontera expressed optimism about the submission aligning with European study results and the potential market leadership in PDT for cutaneous oncology [7]. - A board-certified dermatologist highlighted the study's findings as reinforcing the value of Ameluz-PDT for treating sBCC [7].