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A Phase 2b Randomized, Double-Masked, Sham-Controlled, Study to Evaluate the Efficacy and Safety of Intravitreal Injection of MCO-010 Optogenetic Therapy in Adults With Retinitis Pigmentosa [RESTORE]

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Trial Profile

A Phase 2b Randomized, Double-Masked, Sham-Controlled, Study to Evaluate the Efficacy and Safety of Intravitreal Injection of MCO-010 Optogenetic Therapy in Adults With Retinitis Pigmentosa [RESTORE]

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Jul 2025

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At a glance

  • Drugs Sonpiretigene isteparvovec (Primary)
  • Indications Retinitis pigmentosa
  • Focus Registrational; Therapeutic Use
  • Acronyms RESTORE
  • Sponsors Nanoscope Therapeutics

Most Recent Events

  • 14 Jul 2025 According to a Nanoscope Therapeutics media release, a rolling BLA submission to the FDA has been initiated following positive results from this study. The FDA has granted Nanoscope rolling review of its BLA, with the first modules already submitted and full BLA submission anticipated in early 2026. It is eligible for priority review under fast-track designation.
  • 31 Oct 2024 According to a Nanoscope Therapeutics media release, positive 2-year results from the Phase 2b RESTORE were presented by Allen C. Ho, MD, FACS, FASRS, Director of Retina Research and Co-Director of the Retina Service at Wills Eye Hospital, and Chief Medical Advisor of Nanoscope, on October 20, 2024 at the recently concluded AAO 2024 Annual Meeting.
  • 31 Oct 2024 Results (positive 2-year) presented in a Nanoscope Therapeutics media release.

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