Nanoscope Therapeutics
Nanoscope CEO Sulagna Bhattacharya
Nanoscope Therapeutics Inc., a clinical-stage biotechnology company founded in Fort Worth developing gene therapies for retinal degenerative diseases, on Monday said that the U.S. Food and Drug Administration has granted fast track designation to a therapy it has developed to restore vision in blind patients impacted by retinitis pigmentosa, any group of rare eye diseases that affect the retina.
MCO-010 is an ambient-light therapy through an intravitreal injection.
The FDA’s fast track designation is intended to facilitate the development and expedite the review of novel therapies to treat serious conditions for which there is unmet medical need. With the fast track designation, Nanoscope is eligible for more frequent regulatory meetings and communications with the FDA.
“The FDA’s decision to grant [fast track designation] underscores the importance of MCO-010 to address a serious unmet need and validates its potential as an effective therapeutic for patients with RP,” says Nanoscope CEO Sulagna Bhattacharya in a statement. “We are proud to have the support of the FDA and look forward to collaboratively interacting with FDA to assess next steps in the clinical development and future regulatory review of MCO-010.”
In January, 27 RP patients with advanced vision loss were enrolled in a clinical trial of MCO-010. Top line data from the clinical trial are expected in by June 2023.
In September, enrollment was completed in the Phase 2 clinical trial of MCO-010 in patients with advanced vision loss due to Stargardt disease. Six-month data from the clinical trial are expected by June 2023.