Nanoscope Announces Groundbreaking 3-Year REMAIN Trial Data for Patients with Retinitis Pigmentosa at 2025 Euretina Congress and Retina Society Annual Scientific Meeting
PR Newswire
DALLAS, Aug. 26, 2025
- Talks highlight efficacy, durability, and safety of Nanoscope's MCO (multi-characteristic opsin) optogenetic therapy platform
- Data forms the foundation for recent rolling Biologics License Application submission with the FDA for retinitis pigmentosa
DALLAS, Aug. 26, 2025 /PRNewswire/ -- Nanoscope Therapeutics Inc., a biotechnology company committed to developing and commercializing novel disease-agnostic therapies for patients with photoreceptor loss and vision impairment from retinal degeneration, will present compelling new data from its RESTORE long-term follow-up study, REMAIN, at the 2025 Euretina Congress and Retina Society Annual Scientific Meeting. The presentations highlight positive 152-week efficacy and safety results for MCO-010 (sonpiretigene isteparvovec), the company's lead optogenetic therapy for retinitis pigmentosa (RP). MCO-010, delivered as a one-time, in-office intravitreal injection, is the first and only therapy in a randomized, controlled trial shown to restore vision in RP patients with severe vision loss.
"Durable efficacy and long-term tolerability are meaningful for patients suffering from irreversible, progressive vision loss due to RP, and underscore the potential of MCO-010 to redefine the standard of care for these patients.", said Dr. Samarendra Mohanty, President and Chief Scientific Officer, Nanoscope. "It is an exciting time at Nanoscope as we prepare MCO-010 for commercialization, kicked off by the recent initiation of our rolling BLA with the FDA."
Following are the details of the presentations:
2025 Euretina Congress, Paris, France:
Title: | REMAIN: 152-Week Extended Analysis From the RESTORE Study of MCO-010 Optogenetic Therapy for Retinitis Pigmentosa |
Session Title: | Free Paper 11 - Inherited Retinal Diseases |
Session Date: | Friday, September 5 |
Session Time: | 5:24 pm CET |
Presenter: | Jordi Monés, MD, PhD; Director, Institut de la Macula, Barcelona, Spain |
2025 Retina Society Annual Meeting, Chicago, Illinois, USA:
Title: | REMAIN: 152-Week Extended Analysis from the MCO-010 Optogenetic Therapy for Retinitis Pigmentosa RESTORE Study |
Session Title: | Genetic Diseases, Dystrophies, Degenerations |
Session Date: | Wednesday, September 10 |
Session Time: | 3:44 pm CDT |
Presenter: | Christine Kay, MD; Vitreoretinal Associates, Director of Clinical Research and Retinal Genetics |
For more information on MCO and Nanoscope Therapeutics visit: www.nanostherapeutics.com.
About Nanoscope Therapeutics
Nanoscope Therapeutics is developing disease-agnostic, vision-restoring optogenetic therapy for millions of patients blinded by retinal degenerative diseases. Following positive results from the RESTORE Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trial for retinitis pigmentosa (RP) (NCT04945772), a rolling BLA submission to the FDA has been initiated. If approved, MCO-010 has the potential to be the standard of care for RP patients, administered as a one-time, in-office injection without the need for genetic testing. The company has also shown promising results in the STARLIGHT Phase 2 clinical trial of MCO-010 in Stargardt disease (SD) (NCT05417126) and plans to initiate a Phase 3 registrational trial in 2025. MCO-010 has received FDA Fast Track and Orphan Drug designations for both RP and SD and EMA Orphan Designation to cover non-syndromic and syndromic rod- and cone-dominant dystrophies, as well as macular dystrophies. A Phase 2 program for MCO in geographic atrophy (GA) patients is expected to start by the end of 2025. Other IND-ready programs include Leber congenital amaurosis (LCA).
Contact:
Nanoscope Therapeutics
(817) 857-1186
PR@nanostherapeutics.com
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SOURCE Nanoscope Therapeutics
