Optiscan and Long Grove Forge Exclusive US Partnership to Advance Fluorescein Imaging Trials
Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.
- Exclusive five-year collaboration agreement between Optiscan and Long Grove Pharmaceuticals
- Joint development of new clinical applications for fluorescein sodium drug AK-FLOUR®
- Use of AK-FLOUR® with Optiscan’s InVue® device in US clinical trials starting with breast surgery
- Collaboration data to support US FDA regulatory submissions for Optiscan’s surgical imaging device
- Mutual support for FDA supplementary New Drug Applications and regulatory approvals
A Strategic Alliance in Medical Imaging
Optiscan Imaging Ltd (ASX, OIL), an Australian medical technology company, has formalised an exclusive collaboration with US-based Long Grove Pharmaceuticals. This five-year agreement aims to leverage the strengths of both companies to expand the clinical applications of Long Grove’s fluorescein sodium contrast agent, AK-FLOUR®, in combination with Optiscan’s fluorescence-based endomicroscopic imaging devices.
The partnership is particularly focused on supporting clinical studies and trials in the United States, initially targeting breast surgery applications. These trials will generate critical data to underpin regulatory submissions to the US Food and Drug Administration (FDA) for Optiscan’s InVue® surgical imaging device, a cutting-edge tool designed to provide real-time, high-resolution imaging during surgery.
Mutual Benefits and Regulatory Synergies
Long Grove Pharmaceuticals, known for its high-quality pharmaceutical manufacturing and rigorous quality assurance, will supply AK-FLOUR® exclusively for use in these US clinical trials. The collaboration not only facilitates Optiscan’s regulatory pathway by providing access to Long Grove’s existing pharmacokinetic and manufacturing data but also supports Long Grove’s efforts to identify new therapeutic applications for its fluorescein drug.
Optiscan will reciprocate by assisting Long Grove with supplementary New Drug Application (NDA) submissions to the FDA, should new uses for AK-FLOUR® emerge from the combined clinical research. This reciprocal support underscores a strategic alignment that could accelerate market entry and broaden commercial opportunities for both parties.
Expanding Clinical Horizons
While the initial focus is on breast surgery, the collaboration envisions expanding into other surgical and imaging domains, including gastrointestinal endoscopy, robotic surgery, and laparoscopic procedures. This breadth of application highlights the potential for Optiscan’s technology to integrate deeply into diverse surgical workflows, enhancing precision and patient outcomes.
Dr Camile Farah, Optiscan’s CEO, emphasised the significance of this partnership as a milestone in embedding their technology into clinical practice. She noted that the collaboration not only secures a reliable supply of AK-FLOUR® but also provides invaluable clinical data to support regulatory approvals in the lucrative US market.
Looking Ahead
Long Grove’s President, Peter J. Karas, expressed enthusiasm about the partnership’s potential to drive innovation and improve patient outcomes through the fusion of pharmaceutical quality and advanced imaging technology. Together, the companies aim to make a meaningful impact on healthcare delivery.
As the collaboration unfolds, stakeholders will be watching closely for clinical trial progress and regulatory milestones that could unlock significant commercial value and set new standards in surgical imaging.
Bottom Line?
This collaboration marks a pivotal step for Optiscan’s US market ambitions, with regulatory and clinical milestones poised to shape its growth trajectory.
Questions in the middle?
- What are the expected timelines for the completion of clinical trials and FDA submissions?
- How will the collaboration impact Optiscan’s revenue and market penetration in the US?
- Could new clinical applications for AK-FLOUR® emerge beyond the initially targeted surgical areas?
