Biofrontera Submits sNDA to Expand Ameluz PDT for Actinic Keratoses Across the Body

Biofrontera Inc. announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking an expanded indication for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with red light photodynamic therapy (PDT) using the RhodoLED lamp series for the treatment of mild-to-moderate actinic keratoses (AKs) on the extremities, neck, and trunk.

Ameluz PDT is currently FDA approved for the treatment of AKs on the face and scalp and, as of September 2026, for superficial basal cell carcinoma. According to Biofrontera, approval of the latest application would make Ameluz with red light the only PDT approved in the US for AKs across the full body.

“This submission is the next step in converting our clinical program into label expansions,” Hermann Luebbert, chief executive officer and chairman of Biofrontera, said in a statement. He noted that patients frequently develop AKs beyond the face and scalp and that the proposed expansion could allow dermatologists to treat these areas using the same Ameluz product and BF-RhodoLED lamps already used in clinical practice.

Phase 3 Data Support Expanded Indication

The sNDA is supported by results from a multicenter, randomized, double-blind, vehicle-controlled phase 3 trial involving 172 patients with AKs on the extremities, neck, and trunk, as well as a phase 1 maximal-use pharmacokinetic study.

The phase 3 trial evaluated patients with 4 to 15 AK lesions across treatment fields of approximately 80 cm², 160 cm², and 240 cm². Patients received 1 PDT treatment, with a second treatment administered at week 12 if lesions remained.

At 12 weeks following the final PDT treatment, 45.6% of patients receiving Ameluz PDT achieved complete clearance of all treated AK lesions compared with 16.7% of patients receiving vehicle PDT (P < .0003; full analysis set). Patients are being followed for approximately 1 year after their final treatment.

Investigators also reported favorable cosmetic outcomes and patient satisfaction. Aesthetic appearance was rated as “good” or “very good” by investigators in 75.2% of patients and by 70.9% of patients themselves. Additionally, 86.3% of patients indicated that they would choose PDT again for future treatment.

Modified Illumination Protocol

Biofrontera is also seeking approval of an adjusted illumination protocol for all RhodoLED lamps and indications. Under the proposed protocol, light intensity is gradually increased to full intensity, maintained for several minutes, and then cycled on and off until the complete light dose of 37 J/cm² is delivered within a total of 15 minutes.

The protocol is intended to improve tolerability, particularly as PDT-associated pain can increase with larger treatment fields. According to Biofrontera, pain during illumination in the new study was no greater than that reported in a comparable Ameluz PDT study involving treatment fields approximately 4 times smaller.

Potential Role in Full-Body AK Treatment

AKs are common precancerous skin lesions associated with chronic ultraviolet exposure and have the potential to progress to squamous cell carcinoma. Although they frequently occur on the face and scalp, lesions can also develop on other chronically sun-exposed areas, including the arms, legs, neck, chest, and back.

“In my practice I see many patients with AKs well beyond the face and scalp: on the arms, legs, neck, chest and back,” Nathalie Zeitouni, MD, professor of dermatology at the University of Arizona College of Medicine–Phoenix and coordinating investigator of the study, said in the announcement. “Treatment options for these areas are limited, and that remains a real unmet need.”

The FDA typically conducts a filing review within 60 days of receiving an sNDA to determine whether the application is sufficiently complete for substantive review.

References

1. Biofrontera Inc. Biofrontera submits supplemental New Drug Application to FDA to expand Ameluz red light PDT to actinic keratoses on the full body. Published October 8, 2026. Pasted text
2. Eisen DB, Asgari MM, Bennett DD, et al. Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2021;85(4):e209-e233. doi:10.1016/j.jaad.2021.02.082.