Nanoscope Therapeutics announced publication of a peer-reviewed observational study in Documenta Ophthalmologica that examines performance-based measures for assessing meaningful vision changes in patients with severe retinal disease.
The prospective study enrolled 35 subjects, including 25 people with severe vision loss from retinitis pigmentosa and 10 with normal vision, and assessed the reliability and validity of the Multi-luminance Shape Discrimination Test as a functional vision measure. The company notes that the RESTORE Phase 2b/3 randomized, sham-controlled trial of its lead therapy, MCO-010, included MLSDT as a secondary endpoint and that a majority of treated patients improved by two or more luminance levels at Week 52.
The company claims MCO-010 is the first therapy to demonstrate clinically meaningful and statistically significant vision improvements in patients with retinitis pigmentosa and severe vision loss in a registrational trial. Nanoscope is pursuing a rolling BLA submission with the FDA, plans a Phase 3 registrational trial in 2026, and reports multiple regulatory designations across jurisdictions; a Phase 2 program in geographic atrophy and additional IND-ready programs are also noted.
