Biofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC)

Core Viewpoint - Biofrontera Inc. has achieved a significant milestone in its Phase 3 study for the treatment of superficial basal cell carcinoma (sBCC) with Ameluz and RhodoLED PDT, completing the one-year follow-up visit for the last patient in December 2024, which is crucial for the upcoming FDA submission in 2025 [1][4][8] Group 1: Study Details - The Phase 3 study was a double-blind, randomized, placebo-controlled trial involving 187 patients with confirmed superficial BCCs, where participants received two PDT treatments either with Ameluz or placebo [2] - Patients who did not show complete resolution of lesions after three months were retreated, and the FDA has advised Biofrontera to submit a supplemental New Drug Application (sNDA) with the one-year follow-up data [2][3] - Long-term follow-up is essential for dermatology product submissions due to the risk of local recurrence and additional skin cancer development [3] Group 2: Company Statements - Dr. Hermann Luebbert, CEO of Biofrontera, expressed satisfaction with the statistically significant results for both primary and secondary endpoints, indicating strong efficacy of the treatment [3] - The completion of the one-year follow-up is seen as a critical step towards FDA submission and potential label expansion for treating cutaneous malignancies [4] - Dr. Shane Chapman, an investigator in the study, highlighted the impressive results and expressed eagerness to offer Ameluz-PDT as a treatment option for patients with sBCC [5] Group 3: Industry Context - Basal cell carcinoma (BCC) is the most common form of skin cancer in the U.S., with approximately 3.6 million cases diagnosed annually, including a significant subset of superficial BCC [6][8] - BCCs arise from uncontrolled growth of basal cells and, if untreated, can become locally invasive, leading to severe tissue damage [6]