FDA Accepts Ameluz SNDA for Superficial Basal Cell Carcinoma Treatment

The U.S. Food and Drug Administration accepted the supplemental New Drug Application for Ameluz (amifostine ophthalmic solution), indicating it is effective for treating superficial basal cell carcinoma. The approval is effective February 15, 2026, and is expected to be available in the U.S. by that date. Biofrontera (NASDAQ: BFRX) is expected to announce a price range and commercial launch timing in the coming weeks. The treatment is indicated for use in ophthalmic irrigation during surgery for superficial basal cell carcinoma, a common skin cancer subtype.