AMELUZ (aminolevulinic acid hydrochloride) topical gel, 10% with RhodoLED photodynamic therapy
Superficial basal cell carcinoma · Patients with superficial basal cell carcinoma
BFRI · Biofrontera Inc
Full timeline
4 milestonesFDA decision expected
FDA assigned a September 28, 2026 PDUFA target action date to the AMELUZ photodynamic-therapy sNDA for superficial basal cell carcinoma.
Biofrontera — FDA filing acceptance and PDUFA date↗FDA accepted the sNDA for filing
FDA completed its filing review and accepted the supplemental application covering AMELUZ gel used with the RhodoLED red-light lamp series.
Biofrontera — FDA filing acceptance↗The Phase 3 study reported positive topline results
In ALA-BCC-CT013, AMELUZ-PDT achieved the primary composite clinical and histological clearance endpoint in 65.5% of patients versus 4.8% with placebo-PDT.
Biofrontera — Positive Phase 3 sBCC results↗Phase 3 superficial BCC study started
The randomized multicenter study began evaluating Ameluz photodynamic therapy against placebo in patients with superficial basal cell carcinoma.
ClinicalTrials.gov — Ameluz superficial BCC study record (NCT03573401)↗Related News
Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma
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