AGTC files investigational new drug application for gene therapy product

Applied Genetic Technologies Corp. has filed an investigational new drug application with the FDA to conduct a phase 1/2 clinical trial of its gene therapy product candidate for treating achromatopsia, according to a company press release. The adeno-associated virus-based gene therapy is under consideration as treatment for achromatopsia caused by mutations in the CNGB3 gene. A multicenter clinical study in the U.S. is planned to evaluate safety and efficacy of the gene therapy product, according to the press release