Nanoscope Therapeutics Inc., a biotechnology company committed to developing and commercializing novel, disease-agnostic therapies for patients with photoreceptor loss and vision impairment due to retinal degeneration, today announced that Dr. Jordi Monés and Dr. Allen C. Ho will present Phase 2b/3 RESTORE and Long-Term-Follow-Up REMAIN study results at the FLORetina-ICOOR 2025 Congress, December 4th-7th at the Fortezza da Basso in Florence, Italy. The presentations highlight the positive 3-year efficacy and safety results demonstrated by Nanoscope's proprietary optogenetic therapy, MCO-010, from a single, intravitreal injection in patients having severe vision loss from Retinitis Pigmentosa (RP).
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“As demonstrated in these studies, achieving consistent 3-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,” said Jordi Monés, MD, PhD, Director of Institut de la Macula, and Barcelona Macula Foundation. “I am excited to share these results, as well as the strong safety profile of MCO-010, at the FLORetina-ICCOR Annual Congress, which will include some of the world's leading experts in treating vitreoretinal diseases.”
Details for the presentations are as follows:
Title: REMAIN: 3-year Long-term Follow-up from RESTORE Evaluating Efficacy and Safety of MCO-010 Optogenetic Therapy in Advanced Retinitis PigmentosaPresenter:Jordi Monés, MD, PhD, Director of Institut de la Màcula, and Barcelona Macula Foundation (Spain)Date / Time: Friday, December 5 | 9:18 CETSession: Highlighted Free Papers 2Location: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 PigmentosaPresenter:Allen C. Ho, MD, Director of Retina Research, Wills Eye Hospital; Chief Medical Advisor, Nanoscope TherapeuticsDate / Time: Saturday, December 6 | 11:18 CETSession: Retina Futura – Spotlight on Emerging Therapies for Inherited Retinal DiseasesLocation:Sante Croce Room
MCO-010 has been granted Fast Track and Orphan Drug designation by the U.S. FDA, and a rolling Biologics License Application (BLA) for retinitis pigmentosa is currently underway. The European Medicines Agency has granted MCO-010 five Orphan designations across a wide spectrum of retinal degenerations involving photoreceptor loss.
About the MCO PlatformMCO is a one-time, in-office, intravitreal disease-agnostic therapy platform designed to restore vision in patients with photoreceptor degeneration, including Retinitis Pigmentosa (RP), Stargardt disease (SD), and geographic atrophy (GA). By activating highly dense bipolar retinal cells to become light sensitive, MCO utilizes the remaining visual circuitry following photoreceptor death. MCO treatment does not require genetic testing, invasive surgery, or repeat dosing, enabling broad patient applicability within existing retina office workflows.
About Nanoscope TherapeuticsNanoscope 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/3 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 trialin 2025. MCO-010 has received FDA Fast Track and Orphan Drug designations for both RP and SD, along with RMAT designation for SD, and EMA Orphan designations 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) is expected to start by the end of 2025. Other IND-ready programs include Leber congenital amaurosis (LCA).
Contact:Nanoscope Therapeutics(817) 857-1186PR@nanostherapeutics.com
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