Biofrontera completes Phase 1 study for Ameluz, sets FDA submission for 2026.

Thursday, Dec 4, 2025 9:06 am ET1min read

Biofrontera has completed the final patient visit in its Phase 1 pharmacokinetic study for Ameluz, a treatment for actinic keratoses on peripheral body areas. This marks a key milestone for FDA submission in summer 2026. The study, along with results from a recent Phase 3 clinical trial, will form the basis for FDA approval.

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