Biofrontera Phase 3 Ameluz® PDT meets primary endpoint for AK on extremities/neck/trunk

Biofrontera Inc.

Complete clearance 45.6% (Ameluz®) vs 16.7% (vehicle), p<0.0003 in FAS.
Per protocol set complete clearance 53.2% vs 22.2% (p<0.001).
Study enrolled 172 patients randomized 4:1; lesion clearance rate 73.1% (FAS).
Cosmetic outcomes: 75.2% rated 'good/very good'; 86.3% would choose PDT again.
sNDA submission to FDA planned for Q3 2026 based on these positive results.

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