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    Researchers image single cell deaths in glaucoma patients

     

    Significantly more spots with glaucoma

    At all doses of ANX776, more spots appeared in glaucoma patients than in healthy subjects and the number of spots in glaucoma patients increased over time. The difference between the glaucoma patients and the healthy subjects was statistically significant (p = 0.0033) and so was the change over time (p = 0.0011).

    A multivariable analysis showed that the total count of DARC spots was 2.37 times higher in patients with glaucoma (p = 0.003) at any dose. The count of these spots correlated with decreased central corneal thickness and increased cup-to-disc ratios.

    It also correlated with age in the healthy subjects. Apoptosis has been associated with healthy ageing as well as being an established risk factor for glaucoma.

    In addition, the more DARC spots a glaucoma patient had, the higher the patient's rate of glaucoma progression. This suggests that "DARC could potentially be prognostic of neurodegenerative activity," the researchers wrote.

    None of the subjects withdrew from the study, or reported any serious adverse events. There were cases of discomfort during phlebotomy, haematoma at the cannulation site, influenza, metatarsal inflammation, dizziness, and headaches, but the researchers did not deem any of these to be related to ANX776.

    The drug was rapidly absorbed and eliminated; exposure appeared to be dose-dependent without accumulation.

    Previous researchers have estimated the number of retinal ganglion cells lost per day to be between 77 and 90 in the whole retina. Assuming that the 30° lens used in this study visualised 30% to 52% of the total retinal ganglion cell death within that field of view (and that all cell death occurs through apoptosis or necrosis), the number of maximal DARC counts in the 0.4 mg ANX776 cohort would be in the predicted range.

    The researchers determined 0.4 mg to be the optimal dose, as this was when they saw the most DARC spots.

    They cautioned that their results are only preliminary.

    "Like any new technology, DARC will need robust testing if it is to be successfully validated," they wrote. "However, these results demonstrate translation from experimental studies where DARC has been used to assess treatment efficacy in addition to disease activity, opening the door for it to be considered as a companion diagnostic endpoint in the indications already investigated experimentally."

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