Last patient completes follow-up for phase 3 study of Ameluz-PDT for basal cell carcinoma
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Key takeaways:
- Ameluz is a topical currently indicated for the photodynamic therapy of actinic keratosis.
- These 1-year results will support Biofrontera’s FDA submission.
A phase 3 study of Ameluz and RhodoLED photodynamic therapy for superficial basal cell carcinoma has reached a key milestone as the final patient has completed the 1-year follow-up visit, Biofrontera announced in a press release.
Ameluz (aminolevulinic acid hydrochloride, Biofrontera) is a topical currently indicated for the photodynamic therapy (PDT) of actinic keratosis. These new results for basal cell carcinoma (BCC) will reportedly be used to support an FDA submission for a new indication.
“The completion of the 1-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,” Hermann Luebbert, PhD, CEO and chairman of Biofrontera, said in the press release. “It demonstrates our continued investment in PDT and supports our vision of partnering with the dermatology community to improve patient care.”
The double-blind, randomized, placebo-controlled study included 187 patients with one or more histologically confirmed superficial BCCs. Each patient received one or two treatments with Ameluz-PDT or placebo-PDT at 1-to-2-week intervals. After 3 months, lesions that were not completely healed were retreated.
The company reports that while these 1-year data will support the FDA submission, the trial is scheduled for 5 more years of follow-up.