Nanoscope Therapeutics releases positive 3-year follow-up data from REMAIN study

Nanoscope Therapeutics has released positive 3-year follow-up data from its REMAIN study, the long-term extension of the phase 2b/3 RESTORE trial (NCT04945772) evaluating MCO-010 in retinitis pigmentosa (RP).

RESTORE was a multicenter, randomized, double-masked, sham-controlled, dose-ranging study evaluating 2 dose levels of MCO-010 in up to 18 patients with RP.

The company defines the MCO platform as a “one-time, in-office, intravitreal disease-agnostic therapy platform designed to restore vision in patients with photoreceptor degeneration.” MCO-010 has been granted Fast Track and Orphan Drug designation by the US FDA, and a rolling Biologics License Application (BLA) is currently underway.

According to the company, results from the REMAIN study showed patients maintained an average best corrected visual acuity (BCVA) gain from baseline of approximately 0.3 LogMAR through week 152. Additionally, BCVA-Area Under the Curve (AUC) profiles across both the RESTORE and REMAIN trials show five times greater vision gains when compared to sham treatment.

No serious ocular adverse events were reported among treated patients, and only 1 mild case of inflammation required topical steroids out of the 15 patients treated.

Sulagna Bhattacharya, CEO of Nanoscope Therapeutics, commented on the follow-up data saying, “These long-term results underscore the lasting impact of MCO-010 in patients who currently have no treatment options. 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 highlights the potential of our platform as a one-time therapy for a broad range of retinal degenerative conditions.”

The company concluded that the REMAIN trial 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 3 years.”

References:

1. Nanoscope Therapeutics Announces Durable 3-Year Vision Improvements from REMAIN Study of MCO-010 in Retinitis Pigmentosa. Published October 22, 2025. Accessed October 24, 2025. https://nanostherapeutics.com/2025/10/22/nanoscope-therapeutics-announces-durable-3-year-vision-improvements-from-remain-study-of-mco-010-in-retinitis-pigmentosa/