Nanoscope Therapeutics Gets Fast Track Designation for MCO-010
Nanoscope Therapeutics has received FDA’s Fast Track designation for its MCO-010, an investigational gene therapy for treatment of retinitis pigmentosa, a group of inherited diseases causing retinal degeneration and vision decline.
MCO-010 delivers a gene directly into the vitreous at the back of the eye. The gene encodes for the light-sensitive multicopper oxidase (MCO) protein into retinal cells and enables the cells to detect light so patients may see again.
In January, 27 retinitis pigmentosa patients with advanced vision loss were enrolled in a multicenter, randomized trial of MCO-010. Top line data from that study are expected in the first half of 2023. Six-month data from a separate phase 2 trial are also expected.
The goal of the FDA's Fast Track designation is to speed the development and review of novel therapies to treat serious conditions for which there is unmet medical need.