Post hoc analysis of GATHER1 on Zimura provides OCT-based support to previous findings
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A post hoc analysis of the GATHER1 clinical trial on Zimura, an investigational new therapy for geographic atrophy, showed the potential to rely on OCT to measure the effect of the treatment on disease progression.
According to a press release from Iveric Bio, manufacturer of Zimura (avacincaptad pegol), “the results of the post hoc analysis showed that OCT-measured GA area strongly correlated with FAF-measured GA area, with minimal average differences in GA area between modalities.”
Fundus autofluorescence (FAF), an imaging modality typically used in geographic atrophy (GA) clinical trials, was used in the GATHER1 trial to measure GA. In the post hoc analysis, OCT showed a 30% reduction in GA growth after 1 year of treatment with Zimura, consistent with the previous findings using FAF. In addition, a 22% reduction in progressive ellipsoid zone integrity loss at 18 months was observed with Zimura vs. sham.
These findings further support the positive outcomes of GATHER1, showing that Zimura might offer an effective therapeutic option for a disease that has no treatment so far. In addition, the release highlighted the possibility of using OCT, a technology that retina specialists are familiar with and equipped with, to accurately diagnose and monitor patients with GA.
Perspective
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This analysis adds two new components to the previous findings of GATHER1. First, it demonstrates that progressive loss of ellipsoid zone integrity was slowed in the treatment groups compared with sham. Further analyses are needed to more specifically understand the functional correlation and impact of these findings on the role for this drug. However, natural history analyses suggested that the ellipsoid zone loss may be a leading and earlier indicator of age-related macular degeneration progression.
This analysis also provided a first assessment of GA measurement from OCT, while the initial analyses were from FAF. The results provided similar findings to the FAF outcomes and showed very strong correlation between OCT-based measurements and FAF-based measurements.
If and how these findings will affect clinical practice remain to be seen. Currently the drug is investigational and not yet available for routine use. The ellipsoid zone findings may provide important information on an earlier biomarker for progressive disease that could potentially be used by clinicians for risk stratification of patients who might benefit from this therapy, but more validation is needed in this area.
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