Iveric Bio to Present Zimura GATHER2 Enrollment and Retention Updates and New GATHER1 Post-Hoc Analyses Today at its Dry Age-Related Macular Degeneration Virtual Symposium for Investors

IVERIC bio, Inc. (Nasdaq: ISEE) announced that today at the Company’s Virtual Symposium for Investors and Analysts, Arshad M. Khanani, MD, MA, of Sierra Eye Associates and Chairman of the GATHER2 Steering Committee, will discuss an accelerated enrollment timeline and patient retention, including injection fidelity, for GATHER2, 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). The Company expects to complete enrollment in GATHER2 in late July of this year. Based on this timeline, the Company 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. The Company also announced that GATHER2 is exceeding patient retention expectations. The Company is targeting patient retention for the trial, as measured by injection fidelity rate through month 12, of greater than 90%. Injection fidelity is calculated by dividing the total number of actual injections by the total number of expected injections based on the number of enrolled patients.

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Proportion of Patients that progress from drusen to iRORA or cRORA (Zimura 2 mg vs. Sham)

“Since the initiation of GATHER2, Iveric Bio has implemented a patient centric strategy with multiple initiatives to tackle the many challenges that the COVID-19 pandemic brought to conducting clinical trials,” stated Dr. Khanani. “It is exciting to be a part of a clinical trial that is exceeding enrollment and retention targets and timelines in the midst of a global pandemic. I believe that the positive results from GATHER1, including the early and continuous treatment effect demonstrated, is a key motivator for the recruitment and retention in the GATHER2 clinical trial.”

“We are thrilled to have world leading retinal specialists participate in our symposium and to share the new post-hoc analyses of GATHER1 and the progress of GATHER2,” stated Dhaval Desai, PharmD, Chief Development Officer of Iveric Bio. “Thus far we have seen an injection fidelity rate well above our target goal of greater than 90% and ahead of our expectations. We consider injection fidelity to be the most important component of patient retention because it reflects the timely administration of the drug into the patient’s eye. We continue to focus as much on retention as recruitment, not only to protect the integrity of our data, but also to potentially demonstrate the early and continuous treatment effect observed in GATHER1.”