Biofrontera Completes Patient Enrollment for Phase 3 Trial of Ameluz in Actinic Keratoses

MT Newswires Live2025-03-18

Biofrontera (BFRI) said Tuesday that it has completed patient enrollment for the phase 3 trial of Ameluz for the treatment of mild to moderate actinic keratoses on the extremities, neck and trunk.

The study enrolled 172 patients and will compare Ameluz with vehicle gel in the field-directed treatment of actinic keratoses, the company said.

Biofrontera expects to complete the study's treatment phase by September and plans to submit a supplemental new drug application to the US Food and Drug Administration in H2 of 2026, pending positive results.

Shares of Biofrontera were up nearly 3% in recent Tuesday trading.

Price: 1.04, Change: +0.03, Percent Change: +2.87

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