Nanoscope Therapeutics announced that the FDA has accepted and filed its Biologics License Application (BLA) for MOGENRY (sonpiretigene isteparvovec/MCO-010), an investigational optogenetic gene therapy for patients with retinitis pigmentosa (RP) and severe vision loss. The application is supported by positive results from the RESTORE Phase 2b/3 trial and long-term REMAIN data, with RESTORE demonstrating improvements in visual acuity at Weeks 52 and 76 and no treatment-related serious adverse events. If approved, MOGENRY could become the first gene-agnostic treatment for RP with severe vision loss, delivered as a one-time, in-office intravitreal injection without requiring genetic testing.
