The Food and Drug Administration (FDA) has granted Fast Track designation to EA-2353 for the treatment of retinitis pigmentosa.
Retinitis pigmentosa is a rare, inherited degenerative eye disease. It is caused by a breakdown and loss of cells in the retina resulting in cell death and loss of vision.
EA-2353 is designed to selectively activate endogenous retinal stem and progenitor cells, which differentiate into photoreceptors. Selective regulation of these endogenous cells may potentially preserve or restore visual function.
The Company is currently investigating the safety, tolerability, and efficacy of EA-2353 administered by intravitreal injection in a phase 1/2a dose-escalation study (ClinicalTrials.gov Identifier: NCT05392751). The trial will include 14 patients with retinitis pigmentosa due to any pathologic genetic mutation.
“This acknowledgement by the FDA of the potential of EA-2353 for RP gives hope for patients living with this devastating degenerative disease,” said Matthias Steger, PhD, MBA, CEO of Endogena. The FDA’s Fast Track designation allows for more rapid regulatory review of the future New Drug Application for EA-2353.
Endogena Therapeutics receives US FDA Fast Track Designation for EA-2353 for the treatment of retinitis pigmentosa. News release. Endogena Therapeutics. February 6, 2023. Accessed February 8, 2023. https://www.globenewswire.com/news-release/2023/02/06/2601932/0/en/Endogena-Therapeutics-Receives-US-FDA-Fast-Track-Designation-for-EA-2353-for-the-Treatment-of-Retinitis-Pigmentosa.html.