PARSIPPANY, NJ–(BUSINESS WIRE)–IVERIC bio, Inc. (Nasdaq: ISEE) announced today that in a mailIn the -hoc analysis of the GATHER1 clinical trial, Zimura showed reduced geographic atrophy lesion growth, compared to sham treatment, at all distances from the foveal midpoint. The analysis was presented by David R. Lally, MD, Director of the Retina Research Institute at New England Retina Consultants, at the American Society of Retina Specialists Annual Meeting in New York, New York.
“The vast majority of patients in GATHER1 had AG lesions within the area that clinicians are most concerned with protecting,” said Dr. Lally. “As a result, the potential benefit of Zimura was observed in a large representative sample of GA patients.”
“The multiple mailThe -hoc analyzes of GATHER1 continue to provide consistent results, giving us great confidence in the strength of the GATHER1 data and the potential of Zimura as a treatment to help a broad population of GA patients,” said Dhaval Desai, PharmD , Director of Development of Iveric Bio.
The analysis reported that approximately 84% of patients had lesions within 500 microns of the foveal midpoint at baseline and that approximately 28% of patients had lesions within 100 microns of the foveal midpoint at baseline. In general, these findings were balanced across all treatment arms and their corresponding sham-control groups in the trial. The attached graphs summarize the results of this post-hoc analysis.
The most frequently reported ocular adverse events were related to the injection procedure. No drug-related adverse events, such as inflammation or endophthalmitis, were reported in GATHER1. No additional safety analysis was performed as part of this post-hoc analysis.
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The complete set of presentation slides is available on the Company’s website at https://investors.ivericbio.com/events-and-presentation.
About GATHER1 and GATHER2
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 primary data from GATHER2, Zimura’s second phase 3 clinical trial for GA, to be available in the third quarter of 2022, approximately one year after the last patient’s enrollment in the trial plus the time needed to block the database and analysis. If the 12-month results of GATHER2 are positive, the company plans to file applications with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) 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 pharmaceutical product and has not been approved for use anywhere in the world. Zimura is designed to target and inhibit the cleavage of the 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 chronic inflammation and cell death associated with the aging process of the retina by decreasing membrane attack complex (MAC) formation and inflammasome activity. , which potentially prevents or slows down the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy.
About Iveric Bio
Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of new treatments for retinal diseases with significant unmet medical needs. The Company is committed to making a positive impact on patients’ lives by providing high-quality, safe and effective treatments designed to treat debilitating diseases of the retina, including the early stages of age-related macular degeneration. For more information about the company, visit www.ivericbio.com.
Any statement in this Press release about Iveric Bio’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about strategy, future operations and future expectations and plans of the Company. and prospects for the Company, and any other statement containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “goal”, “may”, “could”, “plan”, “predict”, “project”, “seek”, “target”, “potential”, “will”, “would”, “could”, “should”, “continue” and similar expressions. In this Press release, the Company’s forward-looking statements include statements about its expectations regarding its development and regulatory strategy for Zimura, including the timing of the receipt of key data from the GATHER2 clinical trial and its plans to seek marketing approval for the geographic atrophy if GATHER2 results are positive, the potential utility of Zimura, and the clinical relevance of clinical trial results and data, including post-hoc analyzes from the GATHER1 clinical trial. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, but are not limited to, those related to the progress and success of research and development programs and clinical trials, advances in the scientific and medical community, and other factors discussed in the “Risk Factors” section contained in quarterly and annual reports. that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the views of the Company only as of the date of this press release. The Company anticipates that subsequent events and developments may cause its views to change. Although the Company may choose to update these forward-looking statements at some time in the future, the Company specifically disclaims any obligation to do so, except as required by law.
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