Biofrontera Inc. completed the database lock for a Phase 1 pharmacokinetics study of its Ameluz® topical gel combined with the BF‑RhodoLED® XL lamp, a key step toward expanding the drug’s indication to treat mild to moderate actinic keratoses on the neck, trunk and extremities.
The study enrolled 17 patients who received a single photodynamic therapy session with three full tubes of Ameluz®. Blood samples collected over a 10‑hour period quantified systemic exposure to 5‑aminolevulinic acid and its metabolite protoporphyrin IX, providing the safety and exposure data needed for a supplemental New Drug Application that Biofrontera plans to file in the third quarter of 2026.
By locking the database, Biofrontera has achieved a regulatory milestone that could broaden the treatable area to up to 240 cm² on additional sun‑exposed body parts. The expansion would increase the product’s addressable market and strengthen its competitive position in the actinic keratosis treatment space, where the current face and scalp indication represents only a portion of the overall disease burden.
The company’s strategy to pursue a broader indication aligns with the growing demand for non‑invasive, outpatient therapies for pre‑cancerous skin lesions. A successful label expansion would allow Ameluz® to be used on a larger surface area, potentially driving higher sales volumes and improving market share against competing photodynamic therapy products.
Biofrontera’s planned sNDA filing in Q3 2026 signals confidence that the Phase 1 data support safety and exposure profiles acceptable to regulators for the new indications. The database lock also demonstrates the company’s ability to execute clinical studies efficiently, a factor that may reassure investors and partners about the company’s development capabilities.
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