Nanoscope Therapeutics' MOGENRY Gene Therapy Advances Toward FDA Approval for Retinitis Pigmentosa

Nanoscope Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for MOGENRY (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy aimed at restoring vision in patients with severe vision loss due to retinitis pigmentosa (RP). If approved, MOGENRY would become the first gene-agnostic treatment available for RP patients experiencing significant vision impairment. The BLA submission is supported by positive data from the RESTORE Phase 2b/3 clinical trial and the REMAIN long-term follow-up study. This development marks a significant step forward in providing potential therapeutic options for individuals affected by RP.