Nanoscope Therapeutics announced on 9 Sept. 2026 that the U.S. Food and Drug Administration has accepted and filed its Biologics License Application seeking approval of MOGENRY (sonpiretigene isteparvovec, MCO-010), an intravitreal optogenetic gene therapy for patients with retinitis pigmentosa with severe vision loss.
The filing is supported by efficacy and safety data from a Phase 1/2a trial and the RESTORE Phase 2b/3 randomized, double-masked, sham-controlled trial, together with long-term follow-up from the REMAIN study.
The company claims RESTORE met its primary and key secondary endpoints with improvements in visual acuity at weeks 52 and 76 and reports no treatment-related serious adverse events.
According to Nanoscope, MOGENRY is a one-time, in-office intravitreal treatment that does not require genetic testing, invasive surgery, or repeat dosing and, if approved, would be the first gene-agnostic therapy for patients with RP and severe vision loss.
The program has received multiple regulatory designations, and the company plans additional trials in 2026.
