NEW YORK – The US Food and Drug Administration has granted InnoVec Biotherapeutics permission to begin a clinical trial of its investigational gene therapy for neovascular age-related macular degeneration (nAMD), IVB103, the company's contract development and manufacturing organization partner uBriGene Biosciences announced Monday.
IVB103 is an adeno-associated virus (AAV) vector-based gene therapy that Beijing-based InnoVec is developing for nAMD, also known as wet AMD. The late-stage eye disorder is caused by abnormal growth of blood vessels in the retina, stimulated by an excess of vascular endothelial growth factor (VEGF) proteins. Patients with nAMD experience severe and rapid vision loss.
IVB103 is administered intravitreally, or directly into the eye. InnoVec submitted its investigational new drug application for IVB103 to the FDA in May.
In advancing IVB103, InnoVec is joining a growing list of companies developing gene therapies for nAMD. AbbVie and Regenxbio are in the midst of two Phase III trials testing a subretinally administered gene therapy for nAMD, dubbed ABBV-RGX-314. 4D Molecular Therapeutics has plans to kick off a Phase III trial of its intravitreal gene therapy 4D-150 early next year. Adverum Biotechnologies has a Phase II trial underway for ixoberogene soroparvovec, another potential intravitreal gene therapy for the condition.