FDA grants fast track status to Illuminare-1, a nerve imaging agent
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The FDA granted fast track designation to Illuminare-1, a novel nerve visualization agent that locates and delineates nerves during surgery to avoid nerve injury, according to a manufacturer-issued press release.
The agent, developed by Illuminare Biotechnologies in collaboration with Memorial Sloan Kettering Cancer Center, will be evaluated in a first human clinical trial of patients undergoing robot-assisted radical prostatectomy later this year. It is injected in a single dose and consists of a myelin-binding fluorescent agent to provide real-time visualization of nerves as small as 60 micron under blue light illumination, with a duration of activity of 4 to 5 hours, during open and minimally invasive surgery.
Unintended nerve injury during surgery for a variety of conditions can cause loss of function or sensation, muscle atrophy, pain, chronic neuropathy, reduced quality of life, disability and paralysis.
“This is another important milestone for this novel agent and one which we hope will accelerate bringing it to our surgical patients,” Timothy Donahue, MD, lead trial investigator and urologic surgeon at Memorial Sloan Kettering Cancer Center, said in the press release. “The fast track designation by the FDA highlights the unmet need for an agent with the potential to reduce unintended iatrogenic nerve injuries across an array of surgical procedures.”
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