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Abstract #94921 Published in IGR 22-2
Detecting retinal cell stress and apoptosis with DARC: Progression from lab to clinic
Cordeiro MF; Hill D; Hill D; Patel R; Corazza P; Maddison J; Younis SProgress in Retinal and Eye Research 2021; 0: 100976
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 Alzheimer, 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 prediction are reported here. Although further studies are needed to validate these findings, it appears there is potential of 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.
UCL Institute of Ophthalmology, London, UK; Western Eye Hospital Imperial College Healthcare NHS Trust, London, UK; ICORG, Imperial College, London, UK; Novai Ltd, Reading, UK. Electronic address: m.cordeiro@ucl.ac.uk.
Full articleClassification:
3.13.3 RGC Imaging (Part of: 3 Laboratory methods > 3.13 In vivo imaging)
3.9 Pathophysiology (Part of: 3 Laboratory methods)
11.8 Neuroprotection (Part of: 11 Medical treatment)