Iveric Bio Announces Presentation of Post-Hoc Analysis at Macula Society from GATHER1 Clinical Trial of Zimura in Patients with Geographic Atrophy

IVERIC bio, Inc. announced  a post-hoc analysis from the Zimura (avacincaptad pegol) GATHER1 clinical trial which explored enhanced Optical Coherence Tomography (OCT) image analysis to examine the effect of Zimura on change in Ellipsoid Zone (EZ) integrity and growth of OCT-measured geographic atrophy (GA), and to examine the correlation between Fundus Autofluorescence (FAF)-measured and OCT-measured GA progression in the GATHER1 trial. The analysis was presented by Justis P. Ehlers, MD, Cole Eye Institute, Cleveland Clinic, at the Macula Society Meeting in Berlin, Germany.

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“These data further support the positive results of the GATHER1 study and avacincaptad pegol as a potential treatment for patients with GA, who currently do not have any treatment options”

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. As typically used in GA clinical trials, FAF was utilized to measure GA in the GATHER1 clinical trial. A 30% reduction was observed in OCT-measured GA growth with Zimura at 12 months, which is consistent with findings using FAF-measured GA growth in GATHER1. In addition, a 22% reduction in progressive EZ loss/attenuation at 18 months was observed with Zimura compared to sham.

“These data further support the positive results of the GATHER1 study and avacincaptad pegol as a potential treatment for patients with GA, who currently do not have any treatment options,” stated Justis P. Ehlers, MD. “The strong correlation between OCT- and FAF-measured GA area also highlights the potential for ophthalmic specialists to potentially utilize their choice of modality to accurately evaluate patients. In addition, this analysis supports EZ integrity as a potential important endpoint in AMD that deserves further exploration.”

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“This important study illustrates the potential for eye care providers to accurately diagnose and monitor patients with geographic atrophy with OCT alone, without additional equipment required,” said Christopher Simms, Chief Commercial Officer of Iveric Bio. “This is important since OCT imaging technology is believed to be more broadly available across the eye care provider community.”

The analyses were performed in collaboration with The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, at the Cole Eye Institute, Cleveland Clinic, and included macular cube OCT scans from the Zimura 2 mg and 4 mg groups (n=150), and sham group (n=110). The scans were loaded into a machine-learning enhanced OCT mapping software and analyzed for integrity of the outer retinal layers, including the EZ, as well as the sub-RPE compartment. No additional safety analysis was performed as part of the post-hoc analysis.

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