Biofrontera Inc. announced positive Phase 2b results for Ameluz® PDT in treating moderate to severe acne vulgaris, showing greater reductions in inflammatory lesions (57.97% vs. 36.51% vehicle) with the 3-hour incubation regimen versus vehicle. The company plans to present data to the FDA in Q3 2026 to discuss next steps.
Key takeaways
Phase 2b study: 57.97% reduction in inflammatory lesions with Ameluz® (n=20) vs. 36.51% vehicle (n=14) in 3-hour per-protocol population
25% of Ameluz® patients met mIGA co-primary endpoint (clear/almost clear) vs. 21.4% vehicle
Absolute reductions: inflammatory 19.7 (Ameluz®) vs. 15.4 (vehicle), non-inflammatory 23.1 vs. 16.5, total 42.7 vs. 31.9
85.7% of 3-hour Ameluz® patients would choose PDT again; 71.4% rated esthetic outcome good/very good
Plans to present data to FDA in Q3 2026
Most common AEs: burning sensation and pruritus, mild to moderate