Biofrontera Announces Achievement Of Key Milestone In Phase 3 Study Of Ameluz-Photodynamic Therapy In The Treatment Of Superficial Basal Cell Carcinoma Was Met With The Last Patient Completing The 1 Year Follow-Up Visit In December Of 2024

• Last patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024.
• Data from follow-up will be included in FDA submission, expected in Q3 2025.
• Biofrontera announced highly statistically significant results for all primary and secondary endpoints (p <0.0001) in October 2024.
• BCC, of which sBCC is a subgroup, is the most common skin cancer in the US with more than 3 million cases each year1.

WOBURN, Mass., Jan. 08, 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 that a key milestone in its Phase 3 study of the use of Ameluz and RhodoLED PDT in the treatment of sBCC (ALA-BCC-CT013) was met with the last patient completing the 1 year follow-up visit in December of 2024.

The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz® -PDT or placebo-PDT) 1-2 weeks apart. Lesions that were not completely resolved after 3 months were retreated. The FDA has advised Biofrontera to submit the sNDA with one-year follow-up data. While 1-year data will support the FDA submission, the superficial BCC lesions will in total be followed up for five years.

Long-term follow-up studies are often required by the FDA for dermatology product submissions, in particular for skin cancers, and they are important in trials enrolling sBCC patients due to the risk of local recurrence, or subsequent additional skin cancer development.