sNDA Submitted to FDA to Expand Ameluz Indication to Actinic Keratoses on the Extremities, Neck and Trunk – Biofrontera

Biofrontera announced that it has submitted a supplemental New Drug Application (sNDA) to the 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.

“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.” – Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera.

“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.” – Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera.

“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.” – 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.

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<0.0003, Full Analysis Set). In the study, patients received one PDT treatment, with a second PDT treatment administered at Week 12 if any AK lesions remained. Patients are to be followed for approximately one year after their final PDT treatment.

In addition to efficacy, Ameluz PDT demonstrated favorable cosmetic outcomes and high patient satisfaction. Investigators rated the aesthetic appearance of treated skin as “good” or “very good” in 75.2% of patients, while 70.9% of patients reported similar assessments. Consistent with these results, 86.3% of patients indicated they would choose PDT again for future treatment.

The sNDA also includes an adjusted illumination protocol, for which approval is being sought for all RhodoLED lamps and all indications, intended to improve patient tolerability of the illumination. The light is ramped up to full intensity, held for a few minutes, and then cycled on and off until the full light dose of 37 J/cm2 is delivered within 15 minutes in total. PDT-related pain is known to increase with treatment field size; in the new study, pain during illumination with this protocol was no higher than in a comparable Ameluz PDT study in which treatment fields were four times smaller.

Under standard FDA procedures, the agency conducts a filing review within 60 days of receipt of an sNDA to determine whether the application is sufficiently complete to permit a substantive review. The Company will continue to provide an updates.

AK is the most common pre-cancerous skin lesion and is caused by chronic sun exposure; if left untreated, AKs may progress to squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face and bald scalp, but also on other sun-exposed areas of the body. In 2020, approximately 58 million people in the U.S. were affected by AK and 13 million AK treatments were performed.