Submission seeks to extend the Ameluz® label beyond the face and scalp to treatment fields of up to approximately 240 cm² on the rest of the body, with an adjusted illumination protocol
WOBURN, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with PDT using the RhodoLED® lamp series, to include mild-to-moderate actinic keratoses (AKs) on the extremities, neck and trunk.
Ameluz® PDT is currently FDA approved for AKs on the face and scalp and, since September 2026, for superficial basal cell carcinoma (sBCC). If approved, the new indication would make Ameluz® with red light the only PDT approved in the U.S. for AKs on full body.
Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, said: “This submission is the next step in converting our clinical program into label expansions. Coming only weeks after FDA approval of Ameluz® in combination with RhodoLED® red light for superficial basal cell carcinoma, it reflects our strategy of broadening the clinical utility of our red-light PDT platform. Many patients present with AKs well beyond the face and scalp. If approved, this expansion would allow dermatologists to treat these patients with the same Ameluz® product and the BF-RhodoLED® lamps already installed in their practices.” He continued, “Our revenue growth of 12% for the full year 2025 and about 25% for the first half of 2026 demonstrates the increasingly strong market positions of our products. New FDA approvals like that for sBCC and the one just submitted for AKs on the entire body are expected to accelerate revenue growth even further.”
Nathalie Zeitouni, Professor of Dermatology at the University of Arizona College of Medicine – Phoenix and adjunct Professor of Oncology at Roswell Park Comprehensive Cancer Center, and coordinating investigator of the study, commented: “In my practice I see many patients with AKs well beyond the face and scalp: on the arms, legs, neck, chest and back. Treatment options for these areas are limited, and that remains a real unmet need. If approved, extending Ameluz® PDT to the extremities, neck and trunk would give dermatologists a field-directed option for these patients, and I look forward to having it available.”
The submission is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 172 patients with AKs on the extremities, neck and trunk, and by a Phase 1 maximal-use pharmacokinetics (PK) study. In the Phase 3 trial, which evaluated 4 to 15 AK lesions in treatment fields of approximately 80, 160 and 240 cm², using one to three tubes of Ameluz®, 45.6% of patients treated with Ameluz® PDT achieved complete clearance of all treated AK lesions 12 weeks after the last PDT, compared with 16.7% of patients treated with vehicle PDT (p