Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body
Biofrontera submitted an sNDA to the FDA to expand the Ameluz red-light PDT label beyond face and scalp to mild-to-moderate actinic keratoses on the extremities, neck and trunk, with treatment fields up to about 240 cm2. The submission is supported by a Phase 3 trial of 172 patients in which 45.6% achieved complete clearance with Ameluz PDT versus 16.7% with vehicle (p<0.0003), plus a Phase 1 maximal-use PK study and an adjusted illumination protocol intended to improve tolerability.
Key figures
- Drug Name
- Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%
- Revenue Yoy
- 12%
- Phase Of Trial
- Phase 3
- Light dose
- 37 J/cm2
- Phase3 patients
- 172
- Ak treatments 2020
- 13 million
- Us ak prevalence 2020
- approximately 58 million people
- H1 2026 revenue growth
- about 25%
- Treatment field sizes cm2
- [80,160,240]
- Patients would choose pdt again
- 86.3%
- Phase3 complete clearance ameluz
- 45.6%
- Phase3 complete clearance vehicle
- 16.7%
- Cosmetic good or very good investigators
- 75.2%
AI analysis
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