Nanoscope Therapeutics secures pivotal Sakigake and Orphan Drug designations from Japan's MHLW for MCO-010, advancing retinal gene therapy.

SALT LAKE CITY — In this Healio Video Perspective from the ARVO meeting, SriniVas R. Sadda, MD, FARVO, discusses a long-term study evaluating MCO-010 for the treatment of retinitis pigmentosa. Sadda said patients with retinitis pigmentosa experienced sustained improvements in visual acuity through 126 weeks after treatment with MCO-010 (Nanoscope Therapeutics). Additionally, the safety profile of the gene therapy was favorable, he said. “There are other optogenetic therapies also under evaluation, which I think reflects the interest in this space,” he said. “MCO-010 is

KOLOA, Hawaii — In this Healio Video Perspective from Retina 2025, Allen C. Ho, MD, discusses the growing promise of optogenetic therapy in treating patients with retinal disease. Data from a randomized, multicenter, sham-controlled program investigating…

Editor’s note: This is a developing news story. Please check back soon for updates. The FDA accepted a biologics license application for Mogenry, Nanoscope Therapeutics’ investigational therapy designed for vision restoration in retinitis pigmentosa, according to a press release. Mogenry (sonpiretigene isteparvovec), also known as MCO-010, is a one-time intravitreal optogenetic gene therapy. If the therapy is approved, the company said it would be the first gene-agnostic therapy to improve vision in patients with severe vision loss from retinitis pigmentosa. The submission was supported by the

Nanoscope Therapeutics shares long-term data at the Retina Society Meeting in Los Angeles, demonstrating the sustained benefits of MCO-010 therapy for retinitis pigmentosa.

Editor’s note: This is a developing news story. Please check back soon for updates. The FDA accepted a biologics license application for Mogenry, Nanoscope Therapeutics’ investigational therapy designed for vision restoration in retinitis pigmentosa, according to a press release. Mogenry (sonpiretigene isteparvovec), also known as MCO-010, is a one-time intravitreal optogenetic gene therapy. If the therapy is approved, the company said it would be the first gene-agnostic therapy to improve vision in patients with severe vision loss from retinitis pigmentosa. The submission was supported by the

Jordi Monés, MD, PhD, to Introduce First Direct-to-Phase 2 Randomized, Controlled Trial of Optogenetic Therapy in Macular Degeneration Benjamin Bakall, MD, PhD, to Present Durable 3-Year REMAIN Follow-Up Data from the RESTORE Phase 2b/3 Trial of MCO-010 in Retinitis Pigmentosa MONTREAL,...

Image Credit: © Pixel-Shot - stock.adobe.com What clinops professionals need to know The Phase II STARLIGHT trial evaluated a single intravitreal injection of MCO-010 in patients with Stargardt disease, demonstrating meaningful gains in best-corrected visual acuity, including early improvements sustained through 48 weeks. The therapy was well tolerated with no serious adverse events. Based on these results, Nanoscope will advance to the Phase III STARGAZE trial, a randomized, double-masked, sham-controlled study enrolling ~60 patients, with top-line results expected in 2027.

Image Credit: © Pixel-Shot - stock.adobe.com What clinops professionals need to know The Phase II STARLIGHT trial evaluated a single intravitreal injection of MCO-010 in patients with Stargardt disease, demonstrating meaningful gains in best-corrected visual acuity, including early improvements sustained through 48 weeks. The therapy was well tolerated with no serious adverse events. Based on these results, Nanoscope will advance to the Phase III STARGAZE trial, a randomized, double-masked, sham-controlled study enrolling ~60 patients, with top-line results expected in 2027.

/PRNewswire/ -- Nanoscope Therapeutics Inc., a biotechnology company committed to developing and commercializing novel gene-agnostic therapies for patients...

Catalent expands its collaboration with Nanoscope Therapeutics to support clinical trials and commercialization of MCO-010, an innovative optogenetic gene therapy aimed at restoring vision.

Nanoscope Therapeutics will showcase groundbreaking optogenetic therapies focused on retinal diseases at ARVO 2026, highlighting advancements in vision restoration.

Nanoscope Therapeutics has received Orphan Drug Designation in Saudi Arabia for MCO-010, enhancing its global regulatory leadership in vision restoration therapies.

Nanoscope Therapeutics' new study published in Documenta Ophthalmologica explores innovative vision assessment methods for retinal disease patients.

Nanoscope Therapeutics prepares to present post-hoc analyses at the Macula Society Annual Meeting, marking a significant milestone in retinal disease therapies.

Nanoscope Therapeutics will highlight its groundbreaking therapies for vision loss at the 2026 J.P. Morgan Healthcare Conference, showcasing significant regulatory and clinical advancements.

Nanoscope Therapeutics presented groundbreaking results of its MCO-010 optogenetic therapy for retinal degeneration at the FLORetina-ICOOR 2025 Congress in Italy.

Nanoscope Therapeutics announces promising long-term safety results from its MCO-010 therapy study for retinitis pigmentosa, highlighting positive outcomes.

Nanoscope Therapeutics reveals promising three-year results for MCO-010, a potential breakthrough therapy for retinitis pigmentosa with significant vision restoration.

Nanoscope Therapeutics has received significant regulatory approvals for its MCO-010 therapy, aimed at treating retinal diseases, emphasizing its potential for vision restoration.

Nanoscope Therapeutics reveals significant data from their REMAIN trial for retinitis pigmentosa, highlighting advancements in vision restoration therapies.

Nanoscope Therapeutics will showcase crucial data on its MCO-010 therapy for Retinitis Pigmentosa at the 2025 ASRS Annual Meeting, highlighting significant efficacy and safety.