FDA accepts Biofrontera sNDA to allow up to 3 tubes of Ameluz per treatment; PDUFA Oct 4, 2024

Biofrontera Inc.

FDA completed filing review; target action date October 4, 2024 for Ameluz sNDA to increase max dosage from 1 to 3 tubes per treatment.
sNDA supported by two Phase 1 safety studies in 32 and 100 patients; systemic and application site AEs similar to 1-tube use.
Estimated 13M AK treatments annually in US; approval could increase Ameluz utilization by enabling single-visit treatment of larger areas.
CEO Hermann Luebbert stated potential for more convenient treatment and increased US use if approved.

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