Biofrontera Inc. has announced the successful database lock for two clinical studies evaluating Ameluz® photodynamic therapy $(PDT)$ for actinic keratosis (AK) and acne vulgaris. The locked databases pertain to a Phase 3 study for AK on the extremities, neck, and trunk, and a Phase 2 study for moderate to severe acne vulgaris. Data from both studies are expected to be available in February 2026. The results of the Phase 3 AK study will support a planned supplemental New Drug Application (sNDA) to the U.S. FDA in summer 2026 to expand the approved use of Ameluz® PDT. Results from the acne vulgaris study are expected to be presented to the FDA in early Q3 2026 to support a future Phase 3 program.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Biofrontera Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9622265-en) on January 08, 2026, and is solely responsible for the information contained therein.