Detecting retinal cell stress and apoptosis with DARC: Progression from lab to clinic.
Cordeiro Maria Francesca, Hill Daniel, Patel Radhika, Corazza Paolo, Maddison John, Younis Saad
AI Summary
DARC, an imaging technology detecting stressed retinal cells, has progressed to clinical trials, showing potential to predict glaucoma and AMD activity, offering a future biomarker for early disease detection.
Abstract
DARC (Detection of Apoptosing Retinal Cells) is a retinal imaging technology that has been developed within the last 2 decades from basic laboratory science to Phase 2 clinical trials. It uses ANX776 (fluorescently labelled Annexin A5) to identify stressed and apoptotic cells in the living eye. During its development, DARC has undergone biochemistry optimisation, scale-up and GMP manufacture and extensive preclinical evaluation. Initially tested in preclinical glaucoma and optic neuropathy models, it has also been investigated in AMD, Alzheimer's, Parkinson's and Diabetic models, and used to assess efficacy of therapies. Progression to clinical trials has not been speedy. Intravenous ANX776 has to date been found to be safe and well-tolerated in 129 patients, including 16 from Phase 1 and 113 from Phase 2. Results on glaucoma and AMD patients have been recently published, and suggest DARC with an AI-aided algorithm can be used to predict disease activity. New analyses of DARC in GA (Geographic Atrophy) prediction are reported here. Although further studies are needed to validate these findings, it appears there is potential for the technology to be used as a biomarker. Much larger clinical studies will be needed before it can be considered as a diagnostic, although the relatively non-invasive nature of the nasal as opposed to intravenous administration would widen its acceptability in the future as a screening tool. This review describes DARC development and its progression into Phase 2 clinical trials from lab-based research. It discusses hypotheses, potential challenges, and regulatory hurdles in translating technology.
MeSH Terms
Shields Classification
Key Concepts5
DARC with an AI-aided algorithm can be used to predict disease activity in glaucoma and AMD patients, based on recently published results.
New analyses of DARC in Geographic Atrophy (GA) prediction are reported, suggesting the technology has potential as a biomarker, although further validation studies are needed.
DARC (Detection of Apoptosing Retinal Cells) is a retinal imaging technology that uses ANX776 (fluorescently labelled Annexin A5) to identify stressed and apoptotic cells in the living eye.
Intravenous ANX776, used in DARC technology, has been found to be safe and well-tolerated in 129 patients, including 16 from Phase 1 and 113 from Phase 2 clinical trials.
The relatively non-invasive nature of nasal administration of DARC, as opposed to intravenous administration, would widen its acceptability as a screening tool in the future, although much larger clinical studies are needed for it to be considered a diagnostic.
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