Biofrontera Reports Positive Phase 3 Results for Ameluz PDT in Treating Actinic Keratoses Beyond Face and Scalp

Reuters

Feb 09

Biofrontera Reports Positive Phase 3 Results for Ameluz PDT in Treating Actinic Keratoses Beyond Face and Scalp

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.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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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&lt;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.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>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.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU2210149790.SGD","symbol_name":"Natixis Thematics Subscription Economy R/A SGD-H","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260209:nNDL5TjYGh:1","article_id":"2610165690","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2610165690","pubTimestamp":1770646522,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Biofrontera Inc. has announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz photodynamic therapy  with the red-light LED  platform for the treatment of mild to moderate actinic keratoses  on the extremities, neck, and trunk. 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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.\n      \n\n\nDisclaimer: 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. 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