Adverum Biotechnologies, Inc. (ADVM) announced on Thursday that the FDA has granted Regenerative Medicine Advanced Therapy or RMAT designation to Ixo-vec, its gene therapy candidate currently in clinical development for the treatment of wet age-related macular degeneration also known as AMD.
The company said that the RMAT designation is based on the clinical data from Ixo-vec to date.
President and CEO, Laurent Fischer, also stated, "With both RMAT and PRIME designations, we look forward to continuing our close collaborations with both the FDA and EMA on our pivotal program and to sharing updates from regulatory discussions in the fourth quarter of this year."
Wet AMD, also known as neovascular AMD, is a severe form of age-related macular degeneration driven by VEGF, characterized by fluid buildup in the macula and retina.
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