SAN DIEGO, Calif. — September 25, 2026
Alume Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to bevonescein, an investigational fluorescent peptide-dye conjugate being developed as an adjunct for real-time intraoperative visualization of nerves during head and neck surgical procedures in adults. Administered intravenously before surgery, bevonescein selectively binds to nerve tissue and produces a visible fluorescent signal that can help surgeons identify nerves during procedures. The designation follows FDA Fast Track designation granted in 2022 and reflects preliminary clinical evidence supporting the potential of bevonescein to improve a clinically significant aspect of nerve visualization.
Bevonescein Enables Real-Time Nerve Visualization
Bevonescein is designed to highlight nerve tissue during surgery, providing surgeons with direct visual information that may complement conventional approaches to identifying and preserving nerves. Unlike standard intraoperative nerve monitoring based on electromyography, which detects electrical nerve activity, bevonescein is intended to provide visual delineation of nerves during active surgical dissection. The investigational product is a fluorescent peptide-dye conjugate administered intravenously before surgery and can be viewed using fluorescence-capable equipment such as modified surgical loupes or microscopes. Bevonescein remains investigational and has not been approved by the FDA or any other regulatory authority, and its safety and efficacy have not been established.
Phase 3 Program Demonstrates Improved Nerve Conspicuity
Alume has completed three multicenter, prospective, randomized Phase 3 trials evaluating bevonescein in thyroid, parathyroid, parotid and neck dissection procedures. In the trials, nerves were assessed under white light alone and under white light combined with bevonescein-enabled fluorescence. The company reported that fluorescence visualization produced statistically significant improvements in the co-primary endpoint of Nerve Conspicuity across all three Phase 3 trials. In pooled analyses, bevonescein also demonstrated statistically significant improvements in visible nerve length and branching delineation, with p≤0.0001 for each endpoint. Across the Phase 3 program, Alume reported that no serious drug-related adverse events occurred. The Phase 3 findings were presented at the 2026 American Head and Neck Society meeting and the 2026 CORLAS meeting.
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FDA Breakthrough Designation Advances Clinical Development
The FDA’s Breakthrough Therapy Designation is intended to expedite development and review of investigational therapies for serious or life-threatening conditions when preliminary clinical evidence indicates potential substantial improvement over available therapy on a clinically significant endpoint. For Alume, the designation adds regulatory support to the ongoing development of bevonescein following completion of its Phase 3 clinical program. The company is developing the technology for procedures in which critical nerves, including the facial, recurrent laryngeal and spinal accessory nerves, may be at risk of injury. The BTD provides an additional regulatory pathway for interactions with FDA as Alume advances bevonescein toward potential future review, while further regulatory evaluation will be required before the product could become available for clinical use.
Source :Alume Biosciences press release
