Ameluz Gel Approved for Treating Actinic Keratoses
The Food and Drug Administration (FDA) has approved Ameluz (aminolevulinic acid HCl; Biofrontera) gel, in combination with photodynamic therapy (PDT) using BF-RhodoLED lamp, for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp.
The safety and efficacy of Ameluz in combination with PDT using a narrow spectrum source were evaluated in 3 randomized, multicenter trials (Trials 1, 2, 3). All trials included a follow-up assessment after 6 and 12 months. In these trials, 212 patients with 4–8 mild to moderate actinic keratoses lesions on the face/forehead and/or bald scalp were treated with Ameluz and a narrow band spectrum lamp (red light lamp).
The primary endpoint for all trials was complete clearance 12 weeks after the last PDT. In Trial 1, complete clearance 12 weeks after the last narrow spectrum PDT was seen in 85% of patients in the Ameluz group vs. 13% in the vehicle group. In Trial 2, complete clearance was seen in 84% of patients in the Ameluz group vs. 13% in the vehicle group. In Trial 3, complete clearance was seen in 91% of patients in the Ameluz group vs. 22% in the vehicle group.
Ameluz, a porphyrin precursor, undergoes photoactivation after topical application as the prodrug is metabolized to protoporphyrin IX (PpIX). When exposed to appropriate red light, PpIX is activated and causes an excited state of porphyrin molecules. In the presence of oxygen, reactive oxygen species are formed which causes damage to cellular components, and eventually destroys the cells.
Ameluz will be available as a 10% strength gel in 2g tubes.
For more information call (884) 829-7434 or visit Biofrontera.com.