Biofrontera Seeks FDA-Approval of BF-RhodoLED XL for AK

Biofrontera AG, a Germany-based biopharmaceutical company, announced in a company press release¹ that it is seeking FDA approval for its new, larger red-light source for photodynamic therapy (PDT), BF-RhodoLED XL. The device is intended to be used in combination with topical aminolevulinic acid hydrochloride gel 10% (Ameluz) for the treatment of mild to moderate actinic keratoses (AK) on the face or scalp.

The new red-light lamp allows for the treatment of larger surface areas, enabling the device to simultaneously address several actinic keratosis distant from each other.

BF-RhodoLED XL’s function is identical to its predecessor BF-RhodoLED, including light dose, illumination time, and light wavelength, according to the company release.

“The new BF-RhodoLED XL offers an improved control panel with a significantly enhanced graphical user interface and intuitive user navigation,” said Hermann Lübbert, PhD, CEO of Biofrontera. “The lamp’s extremely versatile setting options allow the treatment to be specifically adapted to the needs of each individual patient.”

The company also filed separately to the FDA for aminolevulinic acid hydrochloride to alter the product information allowing up to 3 tubes of the topical to be used per treatment. Currently, the medication is only approved for 1 tube per treatment.

Reference:

1. AG B. Biofrontera submits application for FDA approval of new BF-RhodoLED® XL lamp. GlobeNewswire News Room. Published March 31, 2021. Accessed March 31, 2021. https://www.globenewswire.com/news-release/2021/03/31/2202109/0/en/Biofrontera-submits-application-for-FDA-approval-of-new-BF-RhodoLED-XL-lamp.html