Biofrontera Completes Enrollment and Active Treatment Phase in Phase 3 Ameluz PDT Trial for AK on the Body

Biofrontera recently announced that the final patient has completed the active treatment phase of its phase 3 clinical trial evaluating Ameluz (10% 5-aminolevulinic acid hydrochloride gel) photodynamic therapy (PDT) for mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. As of September 3, 2025, all 172 enrolled patients have entered the 12-month follow-up phase, which is expected to conclude in the second quarter of 2026.¹

The phase 3 trial is a multicenter, randomized, double-blind study comparing Ameluz PDT with vehicle gel in patients with AKs on sun-exposed areas of the body outside the head and neck. PDT was administered with either a RhodoLED or BF-RhodoLED XL lamp following application of 1 to 3 tubes of study gel to areas of approximately 80, 160, or 240 cm². Patients received a single PDT session, with the option for retreatment at 12 weeks if residual lesions were present. The follow-up phase will track recurrence rates and new lesion development over one year.

Pending positive results from the ongoing follow-up phase, Biofrontera plans to submit a supplemental New Drug Application sNDA to the FDA in the second quarter of 2026.

“We are delighted to reach this stage in our clinical program,” said Hermann Luebbert, PhD, CEO and Chairman of Biofrontera, in the news release. “Building on the recent FDA approval for the use of up to 3 tubes of Ameluz per treatment, today’s milestone marks another step in broadening the label and market potential for this product. Together, these developments reflect Biofrontera’s strategic progress toward leadership in PDT.”

Nathalie Zeitouni, MD, Mohs surgeon, clinical investigator at Medical Dermatology Specialists, professor of dermatology at the University of Arizona COM Phoenix, and coordinating investigator of the trial, highlighted the unmet need for new therapeutic options. “We frequently see people with AKs on the trunk and extremities, and current treatment options are limited. Expanding the use of Ameluz PDT to these areas would be a welcome advancement for dermatologists and our patients.”

AK is one of the most common precancerous conditions encountered in dermatology, affecting approximately 58 million adults in the United States. More than 70% of cutaneous squamous cell carcinomas are believed to originate from AK lesions, underscoring the importance of effective treatment strategies beyond the face and scalp.²

Biofrontera’s Ameluz gel wth PDT is also being evaluated for patients with moderate to severe acne in phase 2 trials. Earlier this month, Biofrontera announced the conclusion of its phase 2b study for Ameluz. The multicenter, randomized, double-blind trial compared the photosensitizing agent and porphyrin precursor to vehicle gel when combined with red-light photodynamic therapy.³

One tube of the aminolevulinic acid hydrochloride gel was applied to the entire face, and patients were incubated for either 1 or 3 hours before illumination. The BF-RhodoLED lamp was used to conduct up to 3 photodynamic therapy sessions performed at monthly intervals. The patient follow-up period lasted for 2 months after the final round of photodynamic therapy.

Topline data for Ameluz in patients with acne is anticipated for early next year, with hopes of presenting positive findings to the FDA later in 2026. This indication would pave the way for a phase 3 program, with the eventual goal of achieving FDA approval.

References

1. Biofrontera Inc. announces last patient out in phase 3 study of Ameluz (aminolevulinic acid HCI) topical gel, 10% photodynamic therapy (PDT) for the treatment of actinic keratoses (AK) on the extremities, neck and trunk. News release. GlobeNewswire. September 16, 2025. Accessed September 16, 2025. https://www.globenewswire.com/news-release/2025/09/16/3150998/0/en/Biofrontera-Inc-Announces-Last-Patient-Out-in-Phase-3-Study-of-Ameluz-aminolevulinic-acid-HCI-Topical-Gel-10-Photodynamic-Therapy-PDT-for-the-Treatment-of-Actinic-Keratoses-AK-on-t.html
2. Thomson J, Harwood C, Strid J, Healy E, Wang J. O02 Neoantigens from actinic keratosis are predicted to be more immunogenic than those from cutaneous squamous cell carcinoma – a strategy for immune escape? Br J Dermatol; 2023; 189; https://doi.org/10.1093/bjd/ljad174.002
3. Biofrontera Inc. announces last-patient-out in phase 2b study of Ameluz (aminolevulinic acid HCI) topical gel, 10% for the treatment of moderate to severe acne vulgaris. News release. BioSpace. August 25, 2025. Accessed September 16, 2025. https://www.biospace.com/press-releases/biofrontera-inc-announces-last-patient-out-in-phase-2b-study-of-ameluz-aminolevulinic-acid-hci-topical-gel-10-for-the-treatment-of-moderate-to-severe-acne-vulgaris