SAN DIEGO — Alume Biosciences, Inc. said the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to bevonescein, an investigational agent designed to help surgeons visualize nerves in real time during head and neck surgical procedures in adults.
Bevonescein is an intravenously administered fluorescent peptide-dye conjugate that binds to nerve tissue. Its fluorescent signal is in the visible spectrum, allowing surgeons to see highlighted nerves directly during surgery without a camera, imaging interface or display monitor.
The designation follows the FDA’s Fast Track designation for bevonescein in 2022.
“Iatrogenic nerve injury remains one of the most consequential complications for patients undergoing surgical procedures in the head and neck,” said Quyen T. Nguyen, M.D., Ph.D., Co-Founder and Chief Executive Officer of Alume Biosciences and Professor of Otolaryngology–Head and Neck Surgery and Pharmacology at UC San Diego Health.
“Dr. Nguyen and Alume’s work has, I feel, changed the landscape of modern head and neck cranial nerve surgery. This Breakthrough Therapy Designation recognizes the potential impact of bevonescein, if approved by FDA, for patients undergoing surgical procedures where inadvertent nerve injury is a known risk by allowing improved nerve detection and visualization beyond what is available to the surgical eye alone,” said Gregory W. Randolph, M.D., Professor of Otolaryngology Head and Neck Surgery, Director Thyroid/Parathyroid Endocrine Surgical Division at Massachusetts Eye and Ear Infirmary, Bertucci Endowed Chair in Thyroid Surgical Oncology at Harvard Medical School and one of the clinical trial principal investigators.
Alume has completed three multicenter, prospective, randomized Phase 3 trials of bevonescein in thyroid, parathyroid, parotid and neck dissection surgery.
In each trial, the same nerves were evaluated under white light alone and under white light combined with fluorescence. The company said bevonescein-enabled fluorescence produced a statistically significant improvement in the co-primary endpoint of Nerve Conspicuity in all three trials.
A pooled analysis also showed statistically significant improvements in visible nerve length and branching delineation, with p-values of 0.0001 or less for each measure. No serious drug-related adverse events were reported across the Phase 3 programs, according to Alume.
Phase 3 data were presented at the 2026 American Head and Neck Society meeting in Boston and the 2026 Collegium Otorhinolaryngology Amitiae Sacrum meeting in Groningen, the Netherlands.
The FDA grants Breakthrough Therapy Designation to expedite the development and review of investigational drugs intended to treat serious or life-threatening conditions when preliminary clinical evidence indicates the therapy may offer substantial improvement over available treatment on at least one clinically significant endpoint.
