Optiscan Imaging has entered a five-year collaboration with US drug manufacturer Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein sodium contrast agent used in surgical imaging.
The partnership will support Optiscan’s regulatory push in the US while leveraging Long Grove’s manufacturing expertise and pharmaceutical data.
In particular, the five-year partnership aims to integrate Long Grove’s high-quality pharmaceutical manufacturing capabilities with Optiscan’s advanced imaging technology, supporting clinical studies and regulatory approvals in the United States.
The collaboration will initially focus on breast surgery and expand to gastrointestinal, laparoscopic, and robotic-assisted procedures, Optiscan said in an ASX announcement.
“This collaboration agreement with Long Grove Pharmaceuticals is a clear-cut win-win for both companies’ development strategies,” said Dr Camile Farah, CEO and Managing Director of Optiscan.
“For Optiscan, it 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.”
Long Grove Pharmaceuticals, a US private manufacturer known for its rigorous quality assurance processes and commitment to patient safety, will supply AK-FLUOR® (10% fluorescein sodium injection) for the studies.
The company’s manufacturing standards and regulatory readiness are expected to accelerate Optiscan’s entry into the lucrative US surgical imaging market.
Long Grove will provide critical pharmacokinetic and chemistry, manufacturing, and controls (CMC) data to support Optiscan’s U.S. Food and Drug Administration (FDA) submissions.
In return, Optiscan will assist Long Grove in filing supplementary New Drug Applications (NDAs) should new device-drug uses be identified during the collaboration.
Dr Farah said the agreement reflects growing interest in Optiscan’s proprietary imaging systems. “It provides further evidence that more and more healthcare sector-related groups are wanting to partner with Optiscan’s technology, as they search for ways to enhance and/or expand usage of their own product offerings,” he said.
“Such partnerships will undoubtedly help accelerate the adoption by clinicians of real-time endomicroscopic imaging, which in turn paves the way for improved outcomes for patients undergoing a range of surgical procedures.”
Peter J. Karas, President of Long Grove Pharmaceuticals, added: “We are excited to partner with Optiscan. By combining our dedication to delivering high-quality pharmaceutical products with Optiscan’s advanced imaging technology, we are poised to drive innovation and enhance patient outcomes throughout the healthcare industry. Together, we look forward to making a meaningful impact.”
