The Dallas, Texas-based biotech said it plans to submit a dossier to the FDA later this year after its MCO-010 (sonpiretigene isteparvovec) gene therapy achieved almost all its primary and secondary efficacy objectives in the phase 2b RESTORE trial.
Approximately 100,000 people in the US and an estimated 2 million people worldwide suffer from RP, a condition that results in progressive damage to light-detecting cells in the retina and is the leading cause of inheritable blindness.
