Biofrontera submits FDA sNDA seeking Ameluz label expansion for full-body actinic keratoses
Bitget2026/10/08 13:22Biofrontera filed an sNDA with the FDA to expand Ameluz red-light PDT for mild-to-moderate actinic keratoses beyond face, scalp. Application targets treatment fields up to about 240 cm² on extremities, neck, trunk, positioning Ameluz as potential only full-body AK PDT. Phase 3 data showed 45.6% complete clearance at 12 weeks versus 16.7% for vehicle (p<0.0003). Submission also seeks FDA clearance for a revised RhodoLED illumination protocol intended to improve tolerability across all indications. 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: 202610080922PRIMZONEFULLFEED9842185) on October 08, 2026, and is solely responsible for the information contained therein.
- Biofrontera filed an sNDA with the FDA to expand Ameluz red-light PDT for mild-to-moderate actinic keratoses beyond face, scalp.
- Application targets treatment fields up to about 240 cm² on extremities, neck, trunk, positioning Ameluz as potential only full-body AK PDT.
- Phase 3 data showed 45.6% complete clearance at 12 weeks versus 16.7% for vehicle (p<0.0003).
- Submission also seeks FDA clearance for a revised RhodoLED illumination protocol intended to improve tolerability across all indications.
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
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