Alume Biosciences Secures FDA Breakthrough Therapy Designation for Bevonescein
Alume Biosciences has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for bevonescein, an investigational fluorescent drug being developed to support real-time nerve visualisation during head and neck surgery in adults.
Bevonescein is an intravenous fluorescent peptide-dye conjugate that binds to nerve tissue.
Its visible fluorescent signal is designed to help surgeons identify nerves directly during surgery without the need for a camera, imaging interface or display monitor.
The FDA designation follows Fast Track status granted to bevonescein in 2022.
The company has completed three multicentre, prospective and randomised Phase 3 trials evaluating bevonescein in thyroid, parathyroid, parotid and neck dissection procedures.
The studies compared nerve identification under standard white light with visualisation using white light alongside bevonescein fluorescence.
Across all three trials, bevonescein produced statistically significant improvements in nerve conspicuity.
Pooled results also showed significant improvements in visible nerve length and the delineation of nerve branches.
No serious drug-related adverse events were reported across the Phase 3 programme.
Trial findings were presented at the 2026 American Head and Neck Society meeting in Boston and the 2026 CORLAS meeting in Groningen, the Netherlands.
The BTD is intended to accelerate the development and review of investigational medicines showing preliminary evidence of substantial clinical improvement over available options.
Source: https://www.businesswire.com
