18.97.9.175
dgid:
enl:
npi:0
-Advertisement-
-Advertisement-
Retina

FDA grants fast track designation to AAV-CNGA3 gene therapy for achromatopsia

Posted on

The U.S. Food and Drug Administration has granted fast track designation to AAV-CNGA3 (MeiraGTx Holdings Plc) gene therapy for the treatment of achromatopsia (ACHM) caused by mutations in the CNGA3 gene, according to a press release.

AAV-CNGA3 is designed to restore cone function, delivered to the cone receptors at the back of the eye via subretinal injection.

AAV-CNGA3 is currently being evaluated in an open-label, dose-scalation phase 1/2 clinical trial in patients with ACHM due to mutations in the CNGA3 gene.

“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,” said Alexandria Forbes, PhD, president and chief executive officer of MeiraGTx in the press release. “ACHM is a serious and debilitating disease and we look forward to communicating closely with the FDA as we continue the clinical advancement of AAV-CNGA3.”

Head the full press release here.

-Advertisement-
Related Articles
Wearable collision warning device helps visually impaired individuals
Jul 22, 2021
Psoriasis linked with significantly higher risk of retinal diseases
Jul 20, 2021
Ranibizumab biosimilar has comparable efficacy, safety profile to reference product in patients with nAMD
Jul 19, 2021
-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-