— REMAIN results showed sustained, 3-line vision gains vs baseline through 152 weeks for MCO-010 in patients having severe vision loss from retinitis pigmentosa, and a favorable safety profile
— The data form the clinical basis of a rolling Biologics License Application, initiated in June 2025, with the potential to be the first FDA-approved optogenetic therapy
— MCO platform demonstrates potential as a one-time, disease agnostic optogenetic therapy for patients having severe vision loss
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 positive three-year follow-up data from theREMAIN study, the long-term extension of the Phase 2b/3RESTORE trialevaluatingMCO-010, the Company's proprietary optogenetic therapy for patients withretinitis pigmentosa (RP).
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The REMAIN results demonstrated durable and clinically meaningful vision improvements following a single intravitreal injection of MCO-010, with a favorable safety and tolerability profile maintained through three years.
“The sustained visual gains demonstrated over three years are truly remarkable for this population,” said Allen C. Ho, MD, Director of Retina Research at Wills Eye Hospital and Chief Medical Advisor for Nanoscope. “These patients typically lose about 1.5 lines of vision every five years and often hit legal blindness as early as age 20. The ability to not just slow loss but restore visual function for several years represents a significant therapeutic advance.”
Key Findings from the 152-Week REMAIN Long-Term Follow UpStudy:
— Durable Efficacy:Patients maintained an average Best Corrected Visual Acuity (BCVA)gain from baseline of approximately 0.3 LogMAR(equivalent to three lines or 15 letterson a standard ETDRS vision chart), through Week 152. BCVA-Area Under the Curve(AUC)profiles across both RESTORE and REMAIN show fivefold greater vision gains compared toshamtreatment.
— Favorable Safety:No serious ocular adverse events were reported among treated patients.
— Long-Term Tolerability:Only one mild case of inflammation required topical steroids;14 of 15 treated patients requiredno ongoing inflammation management at Week 152.
“These long-term results underscore the lasting impact of MCO-010 inpatients whocurrentlyhave no treatment options,” said Sulagna Bhattacharya, CEO of Nanoscope Therapeutics.”As we advance our rolling Biologics License Application (BLA) with the FDA for MCO-010 in RP, we are actively preparing for a potential commercial launch of what could become the first approved optogenetic therapy for retinal disease. The treatment durability observed in REMAIN also highlightsthe potential of our platform as a one-time therapy for a broad range of retinaldegenerativeconditions.”
The REMAIN study results were recently presented at several leading ophthalmology conferences, including:
— American Academy of Ophthalmology (AAO) 2025 Annual Meeting (Oct 18-20, 2025) – Allen C. Ho, MD, Wills Eye Hospital, Philadelphia, PA
— Retina Society's 58th Annual Scientific Meeting (Sept 10-13, 2025) – Christine Kay, MD, Vitreo Retinal Associates, Gainesville, FL
— 25TH EURETINA Congress (Sept 4-7, 2025) – Jordi Mones, MD, PhD, Institut de la Màcula, Barcelona, Spain
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.
MCO-010 has been granted Fast Track and Orphan Drug designation by the U.S. FDA, anda 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 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, Inc.+1 (817) 857-1186PR@nanostherapeutics.com
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