#United States #Dallas #Nanoscope Therapeutics #MCO-010 #retinitis pigmentosa

Nanoscope Therapeutics Showcases MCO-010 at FLORetina-ICOOR 2025 Congress

Nanoscope Therapeutics Inc., a pioneer in biotechnology, is making waves with its optogenetic therapy MCO-010, aimed at restoring vision for patients afflicted with retinal degeneration. The recent presentation at the FLORetina-ICOOR Congress in Florence, Italy, from December 4 to 7, 2025, showcased promising results from pivotal studies, including the Phase 2b/3 RESTORE trial and the long-term REMAIN follow-up study.

Key Findings

During the congress, Dr. Jordi Monés and Dr. Allen C. Ho, notable figures in retinal research, presented findings that highlighted the safety and efficacy of MCO-010. The results indicated that a single intravitreal injection had the remarkable ability to sustain a three-line improvement in visual acuity for over three years in patients suffering from Retinitis Pigmentosa (RP), a leading cause of blindness worldwide.

Dr. Monés expressed enthusiasm about the results, emphasizing the breakthrough nature of achieving consistent visual improvement in a condition with limited treatment options. He stated, "As demonstrated in these studies, achieving consistent three-line visual improvement for more than three years from a single dose of MCO-010 is a remarkable outcome for patients with severe vision due to retinitis pigmentosa."

Presentation Highlights

The presentations included:

• - Title: REMAIN 3-year Long-term Follow-up from RESTORE Evaluating Efficacy and Safety of MCO-010 Optogenetic Therapy in Advanced Retinitis Pigmentosa

Presenter: Jordi Monés, MD, PhD
Date / Time: December 5, 2025 / 9:18 CET
Location: Del Carmine Room

• - Title: Longitudinal Efficacy and Safety of MCO-010 Optogenetic Therapy for Vision Restoration in Patients with Severe Vision Loss Due to Retinitis Pigmentosa

Presenter: Allen C. Ho, MD
Date / Time: December 6, 2025 / 11:18 CET
Location: Sante Croce Room

Regulatory Progress

MCO-010 has been designated as a Fast Track and Orphan Drug by the U.S. FDA, with a rolling Biologics License Application (BLA) currently being processed. Additionally, the European Medicines Agency has given MCO-010 five Orphan designations for a range of retinal degenerative diseases that involve photoreceptor loss. This regulatory progress underscores the potential of MCO-010 to alter the treatment landscape for patients affected by these debilitating conditions.

About MCO Platform

The MCO platform represents a significant advancement in the field of vision restoration. It is designed to serve as a one-time, in-office therapy adaptable for various types of photoreceptor degeneration—namely Retinitis Pigmentosa, Stargardt disease, and geographic atrophy. The innovative approach of MCO-010 focuses on activating surviving retinal cells to restore vision without the need for genetic testing or complex surgical procedures. This simplicity opens the door for broader patient application within existing ophthalmology practices.

Nanoscope's Future Directions

Looking ahead, Nanoscope Therapeutics is poised to continue its efforts in advancing vision-restoring therapies. The promising results from its ongoing STARLIGHT Phase 2 trial for Stargardt disease set the stage for a potential Phase 3 registry trial in 2025. With the FDA's favorable designations and positive trial outcomes, MCO-010 could soon become a primary treatment option for patients suffering from Retinitis Pigmentosa and potentially other retinal disorders.

Conclusion

The FLORetina-ICOOR 2025 Congress certainly positioned Nanoscope Therapeutics as a front-runner in the field of optogenetics. With strong efficacy and safety results for MCO-010, the future for patients with retinal degeneration looks brighter than ever. As the company continues to forge ahead with innovative therapies, the hope for restoring vision for millions remains a tangible reality.