Biofrontera Files sNDA For Ameluz-PDT To Treat sBCC After Phase 3 Trial Achieves 65.5% Complete Clearance Of Main Target Lesions; Primary And Key Secondary Endpoints Met With High Statistical Significance With Favorable One-Year Recurrence and Aesthetic Outcomes

• sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025
• First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA
• Primary and key secondary endpoints met with high statistical significance (p <0.0001)
• Favorable recurrence outcomes at one-year follow-up
• BCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually1
  
   

WOBURN, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the submission of an sNDA to the FDA, seeking approval of Ameluz®-PDT for the treatment of sBCC.

The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera's U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz® label to include treatment of sBCC treatment with PDT using its BF-RhodoLED® or RhodoLED® XL red light lamps.

The double-blind, randomized, placebo-controlled, multi-center Phase 3 study evaluated the safety and efficacy of Ameluz®-PDT in 187 patients with one or more clinically and histologically confirmed superficial BCCs. Participants received one cycle of two PDT treatments (either Ameluz®-PDT or placebo-PDT) 1-2 weeks apart. If required, a second treatment cycle was repeated at three months.

The study's primary endpoint was a composite measure of complete clinical and histological clearance of one preselected "main target lesion" (MTL) at 12 weeks after the start of the last PDT cycle. This rigorous target was achieved with a 65.5% clearance rate in the Ameluz®-PDT arm (95/145 subjects) compared to 4.8% in the placebo-PDT arm (2/42 subjects), a highly significant statistical difference (p<0.0001).

Key secondary endpoints demonstrated even higher efficacy with (i) complete histological clearance of the MTL seen in 75.9% (110/145) of patients with Ameluz® compared to 19.0% (8/42) with placebo, (ii) complete clinical clearance of the MTL achieved in 83.4% (121/145) of patients treated with Ameluz® compared to 21.4% (8/42) with placebo, and (iii) total clearance of all sBCC lesions in 64.1% of subjects treated with Ameluz compared to 4.8% with placebo (p<0.0001 for all endpoints).

Patient reported outcomes also supported these findings, with a large majority of them – 85.5% – rating the overall treatment satisfaction and aesthetic outcome with Ameluz®-PDT as very good or good. One-year follow-up data further reinforced the durability of response and the long-term cosmetic advantages of Ameluz®-PDT, demonstrating low recurrence rates and excellent aesthetic outcomes.