Nanoscope Therapeutics

Dallas – October 06, 2026 -- Nanoscope Therapeutics will present four-year durability data from its RESTORE Phase 2b/3 trial of optogenetic therapy MCO-010 in retinitis pigmentosa at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting, running October 8–13 in New Orleans.

Four-year REMAIN data to show durability of vision gains in retinitis pigmentosa

Dr. Kenneth C. Fan will present the REMAIN study results on Sunday, October 11, highlighting sustained vision improvement among patients treated with MCO-010 in the RESTORE trial. A separate scientific poster from Dr. David S. Boyer will detail vision improvement with sonpiretigene isteparvovec in dry age-related macular degeneration, drawn from what the company describes as the first direct-to-Phase 2 randomized controlled trial in that indication.

Dallas – October 01, 2026 -- Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has accepted and granted priority review to Nanoscope Therapeutics' New Drug Application for MOGENRY (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy for inherited retinal dystrophies (IRDs). If approved by the Ministry of Health, Labour and Welfare, MOGENRY would become the first disease-agnostic treatment available to IRD patients in Japan, a condition caused by mutations across more than 250 genes that leads to progressive photoreceptor loss and blindness.

Dallas – September 18, 2026 -- Nanoscope Therapeutics will unveil four-year follow-up data showing sustained visual acuity gains from its gene therapy MOGENRY® in retinitis pigmentosa patients, with the FDA already having accepted and filed the company's Biologics License Application.

Christine Kay to present long-term durability data at Retina Society meeting

Dr. Christine Kay, Director of Clinical Research and Retinal Genetics at Vitreoretinal Associates in Gainesville, will present the data on September 23, 2026, at the 59th Annual Scientific Meeting of the Retina Society in Los Angeles. The presentation, titled "Lasting Vision Improvement With MCO-010 Optogenetic Therapy," draws on the REMAIN 4-year extension of the RESTORE Phase 2b/3 trial (NCT04945772) and is scheduled for 3:15 PM PT at the Fairmont Century Plaza Hotel.

Dallas – September 13, 2026 -- The U.S. Food and Drug Administration has accepted and filed the Biologics License Application for MOGENRY, an optogenetic gene therapy from Nanoscope Therapeutics designed to restore vision in retinitis pigmentosa patients with severe vision loss. If approved, MOGENRY would become the first gene-agnostic treatment available for this patient population, which currently has no approved therapy.

RESTORE trial data anchors the regulatory filing

The BLA is supported by the Phase 2b/3 RESTORE trial (NCT04945772), a multicenter, randomized, double-masked, sham-controlled study that met its primary and key secondary endpoints, showing improvements in visual acuity at weeks 52 and 76. No treatment-related serious adverse events were reported. Additional efficacy and safety data come from the earlier Phase 1/2a trial (NCT04919473).