Exegenesis Bio Announces FDA Clearance of Investigational New Drug (IND) Application for EXG102-031; A Novel Gene Therapy for the Treatment of neovascular Age-Related Macular Degeneration (nAMD)

Exegenesis Bio, a rapidly growing global gene therapy company is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EXG102-031, a recombinant adeno-associated virus (rAAV) based gene therapy that is being studied for the treatment of neovascular Age Related Macular Degeneration (nAMD), the leading cause of severe vision loss and irreversible blindness worldwide.

“We are excited by the progress that our company has made and pleased to have reached this critical milestone; this is our second IND approval and the first in North America since the inception of Exegenesis Bio 3 years ago,” stated Zhenhua Wu, CEO of Exegenesis Bio. “This is a strong validation of the world-class R&D, CMC, quality and regulatory capabilities that we have built. We look forward to accelerating development of our innovative gene therapy pipeline in areas with high unmet medical needs and bringing these innovative treatments to patients worldwide.”