Japan Grants Priority Review to Nanoscope’s Vision-Restoring Therapy

The application for MOGENRY, also known as sonpiretigene isteparvovec, targets a broad range of inherited retinal dystrophies. Unlike gene-specific treatments that address individual mutations, this therapy is designed to be disease-agnostic, restoring light sensitivity to surviving bipolar retinal cells regardless of the underlying genetic defect. If approved, the treatment would be administered as a one-time, in-office intravitreal injection, bypassing the need for invasive surgery or specialized genetic screening.

Clinical evidence supporting the submission includes data from the RESTORE Phase 2b/3 trial and the STARLIGHT Phase 2 study. Participants in the RESTORE trial showed measurable improvements in visual acuity at 52 and 76 weeks, with the therapy proving well-tolerated. Nanoscope Therapeutics is simultaneously pursuing regulatory approval in the United States, where a Biologics License Application for the treatment of retinitis pigmentosa is currently under review by the FDA. Company leadership expects that these parallel reviews in major markets will accelerate the availability of the therapy for patients who currently lack effective options.