Research & Development
Iveric Bio Presents Post-Hoc Analysis from GATHER1 Clinical Trial of Zimura in Patients with Geographic Atrophy
4 May 2022 - - US-based Iveric Bio, Inc. (NASDAQ: ISEE) will present a post-hoc analysis evaluating the reduction in geographic atrophy lesion growth observed in patients receiving Zimura (avacincaptad pegol) as compared to patients receiving sham in the completed GATHER1 clinical trial at the upcoming Retinal World Congress in Fort Lauderdale, Florida on May 13, 2022, the company said.

The new results analyze the reduction in GA lesion growth, in a subset of GATHER1 patients, based on the distance of a patient's GA lesion from the foveal center at baseline.

In-line with the overall results of GATHER1, a reduction of GA lesion growth in patients receiving Zimura as compared to patients receiving sham was consistently observed across all baseline distances from the foveal center. No additional safety analysis was performed as part of the post-hoc analysis.

The company previously announced that in GATHER1, Zimura (avacincaptad pegol) met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure.

The company expects topline data for GATHER2, a second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis.

If 12-month results from GATHER2 are positive, the company plans to submit applications with the US Food and Drug Administration and the European Medicines Agency for marketing approval of Zimura for GA.

There are no FDA or EMA approved treatments available for patients with GA.

Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally.

Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b.

By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells.

This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy.

Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.

The company is committed to having a positive impact on patients' lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration.


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