– Analysis Highlights Zimura’s Ability to Slow Disease Progression and Preserve Foveal Anatomy While Sparing the Foveal Center in Patients With AG –
IVERIC bio, Inc. (Nasdaq:ISEE) today announced the completion of post-hoc analysis to assess various parameters of geographic atrophy (GA) growth to study the rate of progression of disease in various areas of the fovea in a subset of patients from the GATHER1 Zimura Phase 3 clinical trial® (avacincaptad pegol) for the treatment of knee OA.
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The accompanying schematic illustrates the five standardized regions (Graphic: Business Wire)
Dr Dhaval Desai, Chief Development Officer of Iveric Bio: “In line with the overall GATHER1 results, the new analysis observed reduced lesion growth in five standardized areas surrounding and including the central foveal area in patients receiving 2 mg of Zimura compared to patients receiving placebo treatment for a period of 18 months. We believe that the observed trend of reduced GA growth is consistent with the natural history of the disease and with recent clinical trial results showing that complement inhibition is associated with a greater reduction in AG growth in patients with non-foveal AG, which is known from natural history to progress more rapidly than AG involving the fovea. This analysis confirms our expectation that we should see a greater reduction in growth away from the foveal center, reflecting the typical circumferential growth pattern of patients with knee OA.”
Dr. Pravin U. Dugel, President of Iveric Bio: “Geographical atrophy has a major impact on functional vision which can alter the quality of life and autonomy of those affected. We believe the results of this exploratory analysis represent a further step in investigating Zimura’s ability to preserve central vision by slowing the progression of knee OA.”
The results of this subgroup analysis are consistent with those of the primary analysis in the intent-to-treat population. Post-hoc analysis assessed GA growth in five standardized areas of the retina in patients for whom images were available at relevant time points (n=47 in the Zimura 2 mg group and n=79 in the placebo group). The five zones included the central foveal zone, consisting of a circle 2 mm in diameter around the central foveal point and four quadrants, temporal, nasal, superior and inferior in a concentric circle 8 mm in diameter around the central foveal point. The attached diagram illustrates the five standard zones.
The graphs show the results of the analysis which will be presented today at the “Angiogenesis, Exudation, and Degeneration 2022” meeting by Dr. Glenn J. Jaffe, Director, Duke Reading Center Chief, Retina Division, Duke Eye Center, Robert MachemerProfessor of Ophthalmology.
Iveric Bio will make the full set of presentation slides available on the Company’s website at https://investors.ivericbio.com/events-and-presentation when presentations begin at 11:00 a.m. ET. East.
About GATHER1 and GATHER2
Iveric Bio previously announced GATHER1’s evidence that Zimura (avacincaptad pegol) met its pre-specified primary efficacy endpoint with statistical relevance in the Phase 3 clinical trial. with Zimura in this trial were related to the injection procedure. The Company estimates that the first data from GATHER2, a second Phase 3 clinical trial of Zimura for the treatment of knee OA, will be available in the second half of 2022, approximately one year after the last patient is enrolled in the trial, plus the time needed to lock the database and analysis. If the 12-month results of GATHER2 are positive, the Company plans to file, with the results of GATHER1 and GATHER2, marketing authorization applications for Zimura for the treatment of knee OA with the US Food and Drug Administration. United States and the European Medicines Agency. There are no US FDA or European Medicines Agency approved treatments available for patients with knee OA.
About Zimura
Zimura (avacincaptad pegol) is an investigational drug that has not yet 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 C5a and C5b fragments. By inhibiting the formation of these fragments, Zimura is thought to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by reducing membrane attack complex (MAC) formation and the activity of inflammasome, thereby potentially preventing or slowing down the degeneration of the retinal pigment epithelium. This potential mechanism is the rationale for Zimura as a potential treatment for geographic atrophy.
About Iveric Bio
Iveric Bio is a science-based biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases for which there are 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 diseases of the retina, including the early stages of age-related macular degeneration. For more information on Iveric Bio, visit www.ivericbio.com.
Forward-looking statements
Any statements contained in this press release or made in connection with the announced presentation regarding Iveric Bio’s future expectations, plans and prospects are forward-looking statements within the meaning of the provisions of the Private Securities Litigation Reform Act of 1995. forward-looking statements include all statements about the Company’s strategy, future operations and the Company’s expectations, plans and prospects, as well as any other statements containing the words “anticipate”, “believe”, “estimate”, “expect” , ‘intend’, ‘goal’, ‘may’, ‘could’, ‘plan’, ‘predict’, ‘project’, ‘seek’, ‘target’, ‘potential’, ‘will’, ‘would ”, “could”, “should”, “continue”, and other similar expressions. In this press release, the Company’s forward-looking statements include statements relating to its expectations regarding the development of Zimura and related regulatory strategy, its plans regarding additional indications, such as intermediate AMD, that the Company could implement for the purposes of the development of Zimura, the potential usefulness of Zimura and the clinical relevance of the results of clinical trials. These forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development plans, future results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, those related to the progress and success of research and development programs and clinical trials, and other factors mentioned under the heading “Risk Factors” contained in the quarterly and annual reports filed by the Company with the Securities and Exchange Commission. Any forward-looking statement expresses the Company’s views only as of the date of this press release. The Company acknowledges that subsequent events and developments may alter its views. Although the Company may elect 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.
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