Nanoscope Unveils Pioneering 3-Year REMAIN Trial Results for Vision Restoration

Nanoscope Therapeutics Presents Groundbreaking Data

In a significant advancement in vision restoration therapies, Nanoscope Therapeutics Inc., a biotechnology firm focused on developing innovative treatments for retinal degeneration, unveiled promising results from its 3-year REMAIN trial at the 2025 Euretina Congress and Retina Society Annual Scientific Meeting. These findings top the agenda, emphasizing the efficacy, durability, and safety of its lead optogenetic therapy, MCO-010 (sonpiretigene isteparvovec), specifically aimed at patients suffering from retinitis pigmentosa (RP).

A New Hope for Patients with Retinitis Pigmentosa

The company’s RESTORE long-term follow-up study showcased encouraging outcomes over a 152-week period. According to Dr. Samarendra Mohanty, the President and Chief Scientific Officer of Nanoscope, the results signify a substantial step forward in providing a novel treatment standard for those afflicted by irreversible vision loss due to RP. MCO-010, which is administered through a single, in-office intravitreal injection, stands out as the only therapy in a randomized controlled trial that demonstrated the potential to restore vision in patients experiencing severe vision impairment.

Details of the Presentation

At the Euretina Congress in Paris, Dr. Jordi Monés, MD, PhD, Director of the Institut de la Macula in Barcelona, presented a detailed analysis. His session, titled "REMAIN 152-Week Extended Analysis From the RESTORE Study of MCO-010 Optogenetic Therapy for Retinitis Pigmentosa," took place on Friday, September 5, at 5:24 PM CET. In addition, at the Retina Society Annual Meeting in Chicago, Dr. Christine Kay, MD, Director of Clinical Research and Retinal Genetics at Vitreoretinal Associates, presented findings from the same study on Wednesday, September 10.

Addressing a Critical Need

The data reported not only highlight the positive responses but also the significant safety parameters for MCO-010. This data has been pivotal in Nanoscope’s recent submission of a rolling Biologics License Application (BLA) to the FDA, aiming to bring this innovative therapy to market.

Dr. Mohanty elaborated on the implications of these findings, stating, "The durability of efficacy and long-term tolerability are critically important for patients dealing with progressive vision loss due to retinitis pigmentosa."

Future Directions for Nanoscope

Looking forward, the company continues to emphasize its commitment to the commercialization of MCO-010, which could redefine the therapeutic landscape for retinitis pigmentosa. With the FDA granting both Fast Track and Orphan Drug designations for this treatment, there is an imminent hope for patients requiring urgent solutions.

Nanoscope is additionally preparing to initiate clinical trials evaluating MCO-010 in other retinal conditions, including Stargardt disease, with the STARLIGHT Phase 2 trials already indicating positive trajectories for potential new treatments. Moreover, the company anticipates launching a Phase 2 program for geographic atrophy patients by the end of 2025.

Conclusion

The groundbreaking results from the REMAIN trial signify a beacon of hope for those suffering from retinitis pigmentosa. As Nanoscope Therapeutics progresses towards potential commercialization, it stands at the forefront of a new era in vision restoration, driven by innovative research and unwavering commitment to patient care. For updates and further information about the advancements and developments at Nanoscope, please visit www.nanostherapeutics.com.