IVERIC bio Inc (NASDAQ: ISEE) recently received a written agreement from the USFDA under a Special Protocol Assessment (SPA) for the GATHER2 trial. This trial involves the company’s lead candidate Zimura®, which is meant to treat Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The SPA is a procedure by which the USFDA supports a clinical trial sponsor with an evaluation and guidance on the design of the clinical research protocol. The company expects to complete patient enrolment in GATHER2 by the end of July 2021 and provide topline clinical trial data by 2H2022.
The GATHER2 clinical trial
IVERIC’s GATHER2 clinical trial is designed to support a New Drug Application (NDA) for Zimura®, and the company plans to file an NDA application with the FDA if the proposed clinical trial meets its primary efficacy endpoint. Pravin U. Dugel, President of the company, thanked the FDA for their collaborative interaction and valuable input, through the SPA agreement, on the primary efficacy endpoint. He added that the modification suggested for the primary efficacy endpoint will not require any additional data collection; instead, it suggests a change in analyzing the data. Dugel assured to follow the FDA’s guidance and continue working toward the NDA submission for Zimura®.
The SPA agreement
The USFDA has suggested IVERIC, through the SPA agreement, modify the primary efficacy endpoint to the mean rate of growth estimated based on GA area measured by Fundus Auto Fluorescence (FAF) at baseline 6-month and 12-month. Earlier, the company has proposed to study the mean rate of change in the GA area measured by FAF at identical time points. The company has accepted the SPA agreement and has submitted a revised clinical study protocol and plan for statistical analysis for GATHER2.
Dr. Dugel expressed that the FDA has reviewed and agreed to the modified study protocol and analysis plan submitted for the GATHER2. The FDA has also indicated to consider GATHER1 clinical trial data using the original primary efficacy endpoint, together with the modified analysis plan as revised for GATHER2. The GATHER1 results using FDA’s preferred method are also supportive of the originally reported results.