Iveric Bio, Inc. (NASDAQ: ISEE) is engaged as a biopharmaceutical company, which is focused on the research and development of innovative therapies to treat retinal diseases with unmet medical needs. Shares of the biopharma company shot up 66% during trading on Tuesday, September 6, 2022. Over the past three months, Iveric Bio has seen an average daily volume of 2.11 million shares. However, volume of 128.34 million shares or dollar volume of around $2.01 billion, exchanged hands during the day’s trading session.
Shares of Iveric Bio surged after the company released positive topline results from its GATHER2 Phase 3 clinical trial of Zimura as a treatment for geographic atrophy (GA). GA is an advanced-stage, age-related macular degeneration that causes moderate-to-severe loss of central vision. Currently, there are no approved treatments for GA in the United States or Europe.
The GATHER2 Phase 3 trial data not only showed Zimura meeting its primary endpoint but the treatment was also noted as having a favorable safety profile. The primary endpoint was met after the data showed a 14.3% reduction in the mean rate of growth (slope) in patients’ GA area over twelve months using square root transformation. In addition, the treatment showed a 17.7% reduction using the observed GA area. Further breakdown of the data showed a post-hoc analysis of U.S. patients with a 25.5% reduction using square root transformation and a 32% reduction using observed GA area.
The full results of the GATHER2 trial are scheduled to be presented during the American Academy Ophthalmology Annual Meeting on September 30, 2022, in Chicago. Management also notes they plan to submit a New Drug Application with the U.S. Food and Drug Administration by the end of the first quarter of 2023.
“We are thrilled to see for the first time an investigational therapy with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials,” stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “The results from GATHER1 and GATHER2 and our Special Protocol Assessment with the FDA provide the basis for an NDA, which we are planning to submit by the end of the first quarter of 2023. We look forward to engaging with the FDA throughout the review process. I want to thank the many patients, physicians, and their staffs for their participation in the Zimura clinical program along with the employees of Iveric Bio for their dedication to achieve this important milestone.”
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The post Iveric Bio (NASDAQ: ISEE) Reports Positive Topline Phase 3 Trial Data for Zimura, Plans to Submit FDA New Drug Application Q1 2023 appeared first on Spotlight Growth.
