Optiscan teams up with US drugmaker to support FDA submissions
The exclusive collaborative agreement will see Long Grove's fluorescein sodium contrast dye, AK-FLUOR, supplied for use in Optiscan's InVue imaging system in clinical studies, starting with breast surgery.
Long Grove was founded by US healthcare investor Water Street and is known for its high-quality, cost-effective drug formulations. The company is the legal manufacturer of AK-FLUOR dye. The contrast dye is used to highlight cellular structures for medical imaging during surgery.
Optiscan already uses the dye with its InVue fluorescence-based endomicroscopic imaging technology.
'AK-FLUOR will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials.'
Optiscan chief executive officer and managing director Dr Camile Farah
The two companies have teamed up to explore and support new clinical uses for the injectable dye and will initially focus on breast surgery. The deal is expected to expand into gastrointestinal endoscopy, robotic-assisted surgery and laparoscopic procedures.
The data generated from the trials will be used to fast-track United States Food and Drug Administration (FDA) approvals for both the device and the drug, potentially unlocking broader commercial use and a quicker route into the US market.
As part of the deal, Optiscan will get valuable information about how AK-FLUOR works in the body and how it's manufactured. In return, Long Grove will receive support for new FDA applications if new therapeutic uses of its drug in microscopic imaging come to light from the trials.
Optiscan chief executive officer and managing director Dr Camile Farah said: 'For Optiscan, the agreement gives us a supply of Long Grove's AK-FLUOR, which will be used in combination with our fluorescence-based endomicroscopic imaging devices to undertake studies and clinical trials. The data flowing from these studies will be an invaluable resource for our regulatory submissions. For Long Grove, the collaboration should hopefully identify new uses for its drug.'
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