Iveric Bio Announces Post-Hoc Analysis of Zimura® GATHER1 Clinical Trial at American Society of Retina Specialists Meeting
PARSIPPANY, NJ–(BUSINESS WIRE)–IVERIC bio, Inc. (Nasdaq:ISEE) today announced that in a post-hoc analysis of the GATHER1 clinical trial, Zimura showed reduced growth of geographic atrophy lesions, compared to simulation, across all distances to from the central foveal point. The analysis was presented by David R. Lally, MD, director of the Retina Research Institute at New England Retina Consultants, at the annual meeting of the American Society of Retina Specialists in New York, New York.
“The vast majority of GATHER1 patients had GA lesions in the area that clinicians are most concerned about protecting,” Dr. Lally said. “As a result, the potential benefit of Zimura on a wide range of GA patients was observed.”
“The multiple post-hoc analyzes of GATHER1 continue to provide consistent results, giving us great confidence in the robustness of the GATHER1 data and the potential of Zimura as a treatment to help a large population of patients with knee OA” , Dhaval said. Desai, PharmD, Chief Development Officer of Iveric Bio.
The analysis reported that approximately 84% of patients had lesions within 500 microns of the foveal midpoint at baseline and approximately 28% of patients had lesions within 100 microns of the foveal midpoint at baseline. These results were generally 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 the GATHER1 study. No additional safety analysis was performed as part of this post-hoc analysis.
The full set of presentation slides are available on the Company’s website at https://investors.ivericbio.com/events-and-presentation.
About GATHE1 and GATHE2
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 first data from GATHER2, a second Phase 3 clinical trial for Zimura for GA, to be available in Q3 2022, approximately one year after the last patient was enrolled in the trial. the time needed to lock the database and a scan. If the 12-month GATHER2 results are positive, the company plans to submit applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for marketing approval of Zimura for the ‘AG. There are no FDA or EMA approved treatments for patients with knee OA.
Zimura (avacincaptad pegol) is an investigational drug and has not been approved for use anywhere in the world. 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 thought to decrease or slow the chronic inflammation and cell death associated with the aging process of the retina by decreasing the formation of the membrane attack complex (MAC) and the activity of the inflammasome, thereby potentially preventing or slowing retinal degeneration. retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential treatment for geographic atrophy.
About Iveric Bio
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 positively impacting the lives of patients by providing high quality, safe and effective treatments designed to treat debilitating retinal diseases, including the early stages of age-related macular degeneration. For more information about the Company, please visit www.ivericbio.com.
All statements in this press release regarding 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. include all statements regarding the Company’s strategy, operations and future expectations and the Company’s plans and prospects, and any other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “have intention”, “goal”, “may”, “could”, “plan”, “predict”, “project”, “seek”, “target”, “potential”, “will”, “might”, “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 receipt of key data from the GATHER2 clinical trial and its plans to file a application for marketing authorization for geographic atrophy if GATHER2 results are positive, the potential usefulness of Zimura, and the clinical significance of clinical trial results and data, including post-hoc analyzes of the clinical trial GATHER1. These forward-looking statements involve substantial risks and uncertainties that could cause the development programs, future results, performance or achievements of the Company to differ materially from those expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, those relating to the progress and success of research and development programs and clinical trials, developments 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. All forward-looking statements represent the opinions of the Company only as of the date of this press release. The Company expects that subsequent events and developments may alter its views. Although the Company may choose to update these forward-looking statements at some time in the future, the Company expressly disclaims any obligation to do so, except as required by law.