Biofrontera Inc. (BFRI), Tuesday announced the completion of patient enrollment in its Phase 3 clinical trial for Ameluz or aminolaevulinic acid hydrochloride topical gel, 10 percent, for the treatment of actinic keratoses or AKs on the extremities, neck, and trunk.
This study marks a key step in expanding the use of Photodynamic Therapy or PDT beyond the face and scalp.
The trial aims to assess the safety and efficacy of Ameluz® in treating AKs on sun-exposed areas of the body using PDT with a RhodoLED lamp.
A total of 172 patients were enrolled, with treatments expected to be completed by the third quarter 2025 and follow-up continuing until the second quarter 2026.
Biofrontera plans to submit a supplemental New Drug Application or sNDA to the FDA in the second half of 2026, pending successful results.
This key catalyst highlights Biofrontera's commitment to expanding treatment options for actinic keratoses, a condition affecting millions worldwide.
Currently, BFRI is trading at $1.05 up by 3.96 percent on the Nasdaq.
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