Biofrontera(BFRI) Newsfilter·2025-01-08 14:50Core Insights - 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 [1][4] Study Details - The Phase 3 study was a double-blind, randomized, placebo-controlled, multi-center trial involving 187 patients with confirmed sBCCs, where participants received one cycle of two PDT treatments [2] - The FDA has advised Biofrontera to submit a supplemental New Drug Application (sNDA) with the one-year follow-up data, which will support the submission, while the lesions will be followed for a total of five years [2][3] Long-term Follow-up Importance - Long-term follow-up studies are essential for dermatology product submissions, particularly for skin cancers, due to the risk of local recurrence and additional skin cancer development [3] Company Vision and Future Plans - The completion of the one-year follow-up is crucial for Biofrontera's FDA submission in 2025 and may expand its label for treating cutaneous malignancies, reflecting the company's commitment to photodynamic therapy [4] - Biofrontera aims to partner with the dermatology community to enhance patient care through its PDT products [4] 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, highlighting the significant market potential for effective treatments like Ameluz [6][8]