- The stock price of IVERIC bio Inc (NASDAQ: ISEE) increased by over 30% pre-market. This is why it happened.
The stock price of IVERIC bio Inc (NASDAQ: ISEE) increased by over 30% pre-market. Investors are responding positively to IVERIC bio announcing that they received a written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2 — which is the company’s pivotal clinical trial of Zimura (avacincaptad pegol) in development for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). And as previously announced, IVERIC bio expects to complete enrollment in GATHER2 in late July of this year. Based on the timeline, IVERIC bio expects topline GATHER2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis.
Just like IVERIC bio’s completed GATHER1 clinical trial, GATHER2 was designed to be an adequate and well-controlled clinical trial which, if positive, would support a New Drug Application (NDA) for Zimura in the treatment of GA secondary to AMD. And the SPA agreement further solidifies the IVERIC bio’s plans to file an application with the FDA if the ongoing GATHER2 clinical trial meets its primary efficacy endpoint at 12 months.
In connection with the SPA, the FDA recommended, and IVERIC bio accepted, modifying the primary efficacy endpoint for the GATHER2 trial from the mean rate of change in GA area over 12 months measured by fundus autofluorescence (FAF) at three timepoints: baseline, month 6 and month 12, to the mean rate of growth (slope) estimated based on GA area measured by FAF in at least three timepoints: baseline, month 6 and month 12.
In connection with the SPA, IVERIC bio submitted, and the FDA reviewed, a revised clinical trial protocol and statistical analysis plan (SAP) for the GATHER2 trial reflecting the revised primary efficacy endpoint and agreed upon statistical analysis method. And the original primary efficacy endpoint estimated the mean rate of change in GA area from baseline to month 12, as measured by FAF readings at 3 time points (baseline, month 6 and month 12) without assuming a constant rate of growth over the period. Using the same raw data, the FDA preferred method estimates the mean rate of growth of GA area from baseline to month 12, based on FAF readings at the same three time points (baseline, month 6 and month 12), assuming a constant rate of growth over the period, essentially fitting a straight line based on the data.
In parallel discussions with those for the GATHER2 SPA, the FDA indicated to IVERIC bio that, as part of a future NDA submission for Zimura, the GATHER1 results will be considered using the original prespecified primary efficacy endpoint analysis, together with a post-hoc analysis using the same FDA preferred method that will be used for the GATHER2 trial (mean rate of growth (slope) estimated based on GA area measured by FAF in the relevant timepoints).
“We are excited to receive this SPA agreement from the FDA. We thank the FDA for their collaborative interactions and valuable input on the primary efficacy endpoint for the GATHER2 trial, which we believe reflects the FDA’s current thinking. The modification of the primary efficacy endpoint does not require collecting any new data but instead reflects a change in how the data are analyzed. We look forward to continuing to work with the FDA and following their guidance as we work toward preparing the eventual NDA submission for Zimura.”
“We are pleased that the FDA agrees the design and planned analysis of GATHER2 as modified adequately address the objectives necessary to support an NDA submission. We are also pleased that as part of a future NDA submission, the FDA has indicated that it will consider the GATHER1 data using the original prespecified primary efficacy endpoint analysis, together with the new FDA preferred method that we are using for GATHER2. The data from GATHER1, when analyzed on a post-hoc basis using the FDA’s preferred method, show results that are highly consistent with and strongly supportive of the results we originally reported for GATHER1. We continue to believe GATHER1 will serve as one of the two adequate and well-controlled pivotal clinical trials required for purposes of obtaining marketing approval of Zimura in GA.”
— Pravin U. Dugel, MD, President of Iveric Bio
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