Photodynamic therapy (PDT) specialist Biofrontera has announced that the final patient in its phase 3 skin cancer trial completed the study’s one-year follow-up visit.

The company previously reported "highly statistically significant" results for all primary and secondary endpoints and said the new one-year data for Ameluz-PDT will be included in its submission to the US Food and Drug Administration, which is expected in the third quarter of 2025.

Basal cell carcinomas (BCCs) arise from abnormal, uncontrolled growth of basal cells at the bottom of the epidermis and are most common form of skin cancer, with approximately 3.6 million cases diagnosed in the US every year. 

They rarely spread beyond the original tumour site but, if untreated, can become locally invasive, grow wide and deep into the skin, and destroy skin, tissue and bone.

The late-stage ALA-BCC-CT013 study evaluated the safety and efficacy of Ameluz-PDT in combination with the RhodoLED lamp in patients with one or more clinically and histologically confirmed superficial BCC.

Patients received either Ameluz-PDT or placebo-PDT one to two weeks apart and repeated after three months if required. 

Biofrontera’s chief executive officer, Hermann Luebbert, said: “We were delighted with the highly statistically significant results for the primary and secondary endpoints that we communicated last year. 

“The completion of the one-year follow-up is a crucial milestone in our path to an FDA submission in 2025 and potentially expanding our label to the treatment of a cutaneous malignancy. It demonstrates our continued investment in PDT and supports our vision of partnering with the dermatology community to improve patient care.”