Biofrontera reports Phase 3 sBCC study success; Ameluz-PDT primary endpoint met p<0.0001

Biofrontera Inc.

Primary endpoint: 65.5% complete clearance vs 4.8% placebo (p<0.0001); histological clearance 75.9% vs 19.0%.
Total clearance of all sBCC lesions: 64.1% vs 4.8% (p<0.0001); clinical clearance 83.4% vs 21.4%.
FDA dossier submission expected around end of Q2/early Q3 2025 after 12-month follow-up ends Dec 2024.
Study enrolled 187 patients; double-blind, randomized, placebo-controlled, multi-center design.
BCC is most common skin cancer in US (~3.6M cases/year); sBCC is a subset with limited non-invasive options.

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