FDA grants fast track designation to gene therapy candidate for achromatopsia

The FDA has granted fast track designation to AAV-CNGA3, a gene therapy candidate for the treatment of achromatopsia, according to a press release from MeiraGTx.
AAV-CNGA3, designed to restore cone receptor function via subretinal injection, is currently undergoing a phase 1/2 clinical trial in patients with achromatopsia (ACHM) due to CNGA3 gene mutations.
“We are very pleased to have received fast track designation for AAV-CNGA3 and that the FDA has recognized a significant need exists to quickly advance new therapies for those with ACHM,” Alexandria Forbes, PhD, president and CEO

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