Biofrontera Inc. has announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz® photodynamic therapy $(PDT)$ with the red-light LED (RhodoLED®) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. The multicenter, randomized, double-blind, vehicle-controlled study enrolled 172 patients and met its primary endpoint, demonstrating highly statistically significant superiority for Ameluz® compared to vehicle gel (p<0.0003). Based on these results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the third quarter of 2026. The results have already been announced and presented by the company.

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: GNW9651098-en) on February 09, 2026, and is solely responsible for the information contained therein.