At last check in pre-market trading, shares of IVERIC bio Inc. (ISEE) were up 8.44% to $8.61 this morning. IVERIC stock closed the Friday session at $7.33, which was an increase of 12.31% or $0.87. Shares of the ISEE stock fluctuated between $6.9601 and $8.0495 during the session. Approximately 5.15 million shares were exchanged, increasing over ISEE’s 50-day volume of 0.97 million shares and exceeding its year-to-date volume of 0.74 million shares. The ISEE stock is climbing after receiving FDA approval under Special Protocol Assessment (SPA).
What FDA agreement did ISEE receive?
A science-driven biopharmaceutical company, IVERIC discovers and develops novel treatments for retinal diseases that remain untreated. ISEE is currently working on both treating age-related retinal diseases and developing gene therapy for orphan genetic variant retinal diseases.
IVERIC announced today that the US Food and Drug Administration (FDA) approved the overall design of ISEE’s major trial under a Special Protocol Assessment (SPA).
- ISEE’s GATHER2 trial is designed to reveal Zimurain’s potential as a treatment for age-related macular degeneration (AMD) and geographic atrophy (GA).
- ISEE has announced that enrollment in GATHER2 will be complete by the end of July.
- On this basis, ISEE will provide topline GATHER2 data in 2022, approximately one year after the last patient is enrolled plus the time necessary for database lock and analysis.
- GATHER2 will be a well-controlled, adequate clinical trial similar to ISEE’s GATHER1 clinical trial, which, if positive, would support a New Drug Application (NDA) for Zimura in the treatment of GA secondary to AMD.
- Upon meeting the FDA’s primary efficacy endpoint in the ongoing GATHER2 clinical trial after twelve months, ISEE expects to file an application.
- In connection with the SPA, the FDA recommended, and ISEE accepted, modifying the primary efficacy endpoint for the GATHER2 trial at three timepoints of baseline, month 6 and month 12.
- During SPA negotiations, ISEE submitted a revised clinical trial protocol, as well as a revised statistical analysis plan (SAP) for the GATHER2 trial reflecting the revised primary efficacy endpoint and statistical analysis method agreed upon by the FDA.
What ISEE is expecting further?
IVERIC bio (ISEE) does not need to collect any new data as the primary efficacy endpoint has been modified. Instead, the way data are analyzed has changed. ISEE was subsequently informed by the FDA that the GATHER1 SPA results would be considered in an FDA NDA submission for Zimura, using the prespecified Primary Efficient Endpoint Analysis, plus a post hoc analysis using the same FDA preferred method.
