The FDA has placed a clinical hold on Adverum Biotechnologies’ investigational new drug application for its gene therapy candidate for wet age-related macular degeneration until it receives further information regarding the company’s manufacturing process, according to a press release.
The company completed enrollment and dosing in the first cohort of the phase 1 OPTIC trial of ADVM-022, a single administration gene therapy; however, the FDA requested additional chemistry, manufacturing and controls information and requirements regarding the manufacturing process of ADVM-022, the
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