Nanoscope Therapeutics Secures Key EMA and FDA Designations for Vision-Restoring Therapy
Nanoscope Therapeutics Inc. has received major regulatory milestones for its investigational therapy MCO-010 (sonpiretigene isteparvovec), designed to treat vision loss from retinal degeneration. The European Medicines Agency (EMA) granted Orphan designation across five categories of retinal dystrophies, creating a potential disease-agnostic path for dozens of conditions. Meanwhile, the U.S. FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for Stargardt disease, adding to prior Orphan Drug and Fast Track designations for both Stargardt disease and retinitis pigmentosa. These recognitions highlight MCO-010’s potential to address urgent unmet needs for patients with degenerative retinal diseases.
Nanoscope Therapeutics Secures Key EMA and FDA Designations for Vision-Restoring Therapy