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# Nanoscope BLA Accepted for Vision Restoration Gene Therapy
- URL: https://www.fdaweb.com/nanoscope-bla-accepted-for-vision-restoration-gene-therapy/
- Published: 2026-09-09T12:00:00.000Z
- Updated: 2026-09-13T19:20:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161753

FDA has accepted for review a Nanoscope Therapeutics BLA seeking approval for Mogenry (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration in patients with retinitis pigmentosa (RP) having severe vision loss. “The strength of our RESTORE data, together with the durability we have observed through long-term follow-up in the REMAIN study, give us confidence in MOGENRY’s potential to become a new standard of care for patients living with RP having severe vision loss,” the company says

RESTORE met its primary and key secondary endpoints, showing improvements in visual acuity at weeks 52 and 76, it says, adding that the therapy was well tolerated, with no treatment-related serious adverse events reported.

RP is described as a group of rare inherited disorders in which photoreceptor cells degenerate progressively, leading to impaired vision and eventual blindness. The company says it is one of the leading causes of blindness among the working-age population in the U.S.