Biofrontera reports positive Phase 2b results for Ameluz PDT in moderate-to-severe acne; plans FDA meeting in Q3 2026

Biofrontera Inc.

Phase 2b study: 3-hour Ameluz incubation achieved 57.97% reduction in inflammatory lesions vs 36.51% for vehicle.
25% of Ameluz patients met mIGA co-primary endpoint (clear/almost clear) vs 21.4% with vehicle.
Safety profile consistent with prior PDT; most treatment-related AEs were mild-to-moderate burning and pruritus.
85.7% of 3-hour Ameluz patients would choose PDT again; 71.4% rated esthetic outcome good/very good.
Company to present data to FDA in Q3 2026 to discuss next steps for acne vulgaris indication.

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