Recent news about ameluz pdt

Here is some recent news about Ameluz PDT: 1. **Patient Recruitment Update**: Biofrontera Inc. has provided an update on the patient recruitment for the Phase III clinical study for the treatment of superficial basal cell carcinoma (sBCC) with Ameluz® photodynamic therapy (Ameluz®-PDT) in combination with the BF-RhodoLED® lamp in the U.S. As of the update, 70% of the planned 186 patients have been enrolled, with recruitment expected to complete by the end of 2022. 2. **EU Sales Figures**: In the EU, Biofrontera has reported a significant increase in sales revenue for the months of April to August, following the market launch of Ameluz® in combination with daylight-PDT. Germany, the largest market, saw a 63% increase in sales, with sales more than doubling in June and July compared to the previous year. 3. **FDA Orange Book Listing**: The U.S. patent for BF-RhodoLED® XL, which is used in Ameluz®-PDT, has been listed in the FDA's Orange Book, providing protection for the drug-device combination until October 2040. This listing is a confirmation by the FDA that the patent protects the approved drug and constitutes a hurdle for generic manufacturers. 4. **Financial Results**: Biofrontera Inc. reported record fiscal year 2023 financial results, including a 19% increase in total revenues to $34.1 million compared to the previous year. Despite increased operating expenses, the company achieved an 8% decrease in operating expenses for the fourth quarter of 2023 compared to 2022. 5. **FDA Filing for Supplemental New Drug Application**: Biofrontera announced the filing of a supplemental New Drug Application (sNDA) with the FDA to increase the maximum use of Ameluz® in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy (PDT) using the RhodoLED® XL lamp. The sNDA has a target action date of October 4, 2024. In summary, Ameluz®-PDT has shown positive developments in patient recruitment, sales figures, patent protection, and regulatory filings, indicating a strong position in the dermatological market.