Biofrontera AG [NASDAQ: BFRA] has disclosed that it has submitted an application for New BF-RhodoLED to FDA. The firm is seeking permission for the use of the BF-RhodoLED XL in combination with Ameluz from the FDA. The combination will be used for the cure of minor and reasonable actinic keratoses on the face and scalp.
This is consistent with the current authorization of Ameluz. The intention is to expand the label to include extra indications in the future. The new PDT lamp allows the cure of larger areas as well as the synchronized coverage of several actinic keratoses distant from each other.
The regulatory submission is unbiased of the change in product information presented to the FDA in February. It was presented to permit the use of three tubes of Ameluz per cure but adds it to cure larger areas. Presently, the product data and thus repayment is restricted to the use of one tube of Ameluz per cure.
The new lamp is protected by several patents before submission to the FDA. The cure settings of the new BF-RhodoLED, such as light dose, and wavelength of light are similar to the BF-RhodoLED.