Iveric Bio Reports the US FDA Acceptance of NDA and Granted Priority Review of Avacincaptad Pegol for Geographic Atrophy
Shots:
- The US FDA has accepted the NDA & granted Priority Review for avacincaptad pegol in patients with GA secondary to AMD. The US FDA’s decision is expected on Aug 19, 2023
- The NDA submission was based on the 12mos. pre-specified primary efficacy & safety results from P-III trials (GATHER1 & 2) evaluating avacincaptad pegol (2mg, IVT) in 286 & 448 patients
- The primary efficacy EPs in both studies were based on GA area measured by fundus autofluorescence at three-time points i.e., baseline, 6 & 12mos., the mean rate of growth in GA area from baseline to 12mos. was 35% & 18% in both trials, no events of serious intraocular inflammation, vasculitis, or endophthalmitis were reported 18mos. in (GATHER1) & 12mos. in (GATHER2) trial
Ref: Businesswire | Image: Iveric Bio
Rewlated News:- Iveric Bio’s Zimura (avacincaptad pegol) Receives the US FDA’s Breakthrough Therapy Designation for Geographic Atrophy
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