Novai publishes study supporting use of DARC imaging technology to identify patients at risk of central vision loss from macular atrophy

Novai. a medtech company combatting blindness and disability by pioneering early detection and intervention for eye and brain diseases, today announced the publication of a peer-reviewed study in Expert Review of Ophthalmology, which successfully demonstrates its ‘Detection of Apoptosing Retinal Cells’ (DARC) imaging technology as a promising biomarker for identifying patients at high risk of central vision loss caused by macular atrophy (MA). By revealing disease activity at an earlier stage than currently possible, DARC offers a novel approach to predicting future patterns of atrophy progression, supporting more accurate patient stratification for clinical trials, and earlier initiation of treatment, as appropriate.

MA, also known as late dry-AMD or Geographic Atrophy (GA), is the advanced form of age-related macular degeneration (AMD) which is a leading cause of irreversible vision loss and blindness worldwide. Characterized by the progressive loss of retinal cells responsible for central vision, a key challenge in MA is that retinal cells can become stressed and begin to die long before structural damage is visible on conventional imaging. This has historically limited the ability to identify patients at greatest risk of vision loss. Novai's DARC imaging technology combines a fluorescently labelled Annexin A5 probe with advanced data science, AI-powered algorithms, and digital image processing, to detect and quantify the number and pattern of distribution of sick, stressed, and apoptotic retinal cells in patients, before structural loss becomes apparent.

The paper, titled ‘Predicting directional macular atrophy progression using angular plot analysis of DARC (apoptosing retinal cells), EZ (ellipsoid zone) loss, EZ–RPE (retinal pigment epithelium) difference, and HRF (hyperreflective foci)’, builds on research carried out at Imperial College London, demonstrating the application of Novai’s DARC retinal imaging technology for the detection of early cellular stress, and predicting the directional expansion of atrophy.

The retrospective exploratory study leveraged data from the Phase 2a DARC trial (ISRCTN10751859). The findings demonstrated that baseline DARC measurements were more strongly associated with the future direction of macular atrophy growth than three established optical coherence tomography (OCT) biomarkers, including ellipsoid zone (EZ) loss, EZ-retinal pigment epithelium (RPE) difference, and hyperreflective foci density. DARC signals were also detected beyond the visible margins of existing atrophy, consistent with the identification of stressed and apoptotic photoreceptors before structural damage becomes visible on OCT. Prospective validation of these findings is ongoing in the DAB trial (ISRCTN22122298).

The finding that DARC could provide a window into active disease, including where that disease activity is occurring, at an earlier stage addresses a major unmet need in geographic atrophy. By identifying ongoing cellular activity before irreversible structural loss becomes established, DARC has the potential to identify patients at greatest risk of progression and central vision loss, when there may still be an opportunity to intervene. This is particularly important given the rapidly expanding pipeline of therapies for geographic atrophy, where improved biomarkers of disease activity could help identify the patients most likely to benefit, support earlier and more appropriate treatment, and provide a means of monitoring biological response. While prospective validation is ongoing, DARC could therefore support better informed clinical decision-making, improve clinical trial stratification and, ultimately, enable more personalized treatment and monitoring strategies aimed at preserving vision.”

Maria Francesca Cordeiro, Professor, Founder and CEO, Novai

Novai will be attending the EURETINA Congress 2026 (1-4 October, Vienna, Austria) and the AAO Annual Meeting 2026 (9-12 October, New Orleans, LA, USA). The team will be available to discuss the DARC platform, current and future clinical applications, and potential research and commercial partnerships.