sNDA for Ameluz-PDT as a Treatment for Superficial Basal Cell Carcinoma Submitted to FDA

Biofrontera Inc. announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Ameluz-PDT (photodynamic therapy) as a treatment for superficial basal cell carcinoma (sBCC).1

This December 2 announcement highlights Biofrontera’s sNDA and its incorporation of the complete efficacy results from recent phase 3 research and 1-year follow-up. The company also highlighted its combined safety analysis drawing from both European and US clinical trials in basal cell carcinoma.

“The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in our publication reinforce the value of Ameluz-PDT for the treatment of sBCC,” Todd Schlesinger, MD, director of the Clinical Research Center of the Carolinas in Charleston, South Carolina, and first author of the recent phase 3 results, said in a statement.1 “I look forward to potentially having this as an approved option for my patients with sBCC.”

Actinic keratosis (AK) is a precancerous lesion known to result from long-term sun exposure, with related lesions most often appearing on chronically sun-exposed sites. AK can also progress to squamous cell carcinoma if the condition remains untreated. An estimated 58 million people in the US in 2020 were impacted by AK, with about 13 million treatments taking place.2

In Biofrontera’s announcement, they highlighted basal cell carcinoma (BCC) as the most frequently diagnosed skin cancer nationally, pointing to the over 3 million new cases reported each year. Ameluz-PDT is designed to help address sBCC, a subtype of BCC. If the treatment is cleared by FDA officials, its updated label would permit the use of Ameluz with either the BF-RhodoLED or RhodoLED XL red-light devices for sBCC.

In Biofrontera’s recent phase 3 analysis prior to their sNDA, a double-blind, randomized, placebo-controlled, multicenter study design was used. There were a total of 187 individuals who had at least a single clinically and histologically confirmed superficial BCC included in the study.1 These subjects were given a treatment cycle consisting of 2 PDT sessions with Ameluz-PDT or placebo-PDT. These sessions were administered 1 - 2 weeks apart, with a second cycle provided 3 months later if warranted.

The investigative team’s main endpoint evaluated in their analysis was complete clinical and histologic clearance of a designated main target lesion (MTL) at the 12-week mark following the last cycle of PDT. This benchmark was attained by 65.5% of study participants treated with Ameluz-PDT (95 of 145) as opposed to only 4.8% of subjects in the placebo arm of the analysis.1 This was a difference shown by the investigators to be statistically significant (P < .0001).

In their secondary analyses, even greater relative benefits to Ameluz-PDT were demonstrated by investigators. Histologic clearance of the MTL was observed among 75.9% of those on the treatment, compared with 19.0% in the placebo cohort. Attainment of clinical clearance of the MTL was also observed among 83.4% of the those in the treatment cohort versus 21.4% of those on placebo. Complete clearance of all superficial BCC lesions was also observed by the investigative team in 64.1% of those on Ameluz, compared with 4.8% of participants on the placebo.1 All such comparisons achieved high statistical significance (P < .0001).

The investigators pointed to the alignment of patient-reported outcomes with these clinical findings. Specifically, they highlighted 85.5% of individuals who had rated their satisfaction with Ameluz-PDT and its cosmetic effects to be good or very good. Results from the company’s 1-year follow-up interactions supported the persistence of response. These data would indicate a low rate of recurrence along with sustained cosmetic benefits.

“We are delighted that these highly significant results align with those found in the European studies and that we were able to submit this data package to FDA and seek an extension of the label to include sBCC,” Hermann Luebbert, PhD, CEO and Chairman of Biofrontera Inc., said in a statement.1 “If approved, this would expand the Ameluzindication to cutaneous oncology and would represent a significant milestone in our mission to become market leaders in the field of PDT.”

References

1. Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT. Biofrontera Inc. December 2, 2025. https://www.globenewswire.com/news-release/2025/12/02/3197970/0/en/Biofrontera-Inc-Announces-Filing-of-Supplemental-New-Drug-Application-sNDA-for-the-Treatment-of-Superficial-Basal-Cell-Carcinoma-sBCC-with-Ameluz-PDT.html.

2. Actinic Keratosis Overview. The Skin Cancer Foundation. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/.