Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of retinitis pigmentosa (RP) via intravitreal injection.
“The FDA’s decision to grant FTD underscores the importance of MCO-010 to address a serious unmet need and validates its potential as an effective therapeutic for patients with RP,” said Sulagna Bhattacharya, CEO of Nanoscope. “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 2022, 27 RP patients with advanced vision loss were enrolled in a multicenter, randomized, double-masked, sham-controlled RESTORE clinical trial (NCT04945772) of MCO-010. Top line data from the clinical trial are expected in H1 2023.
In September of this year, enrollment was completed in the Phase 2 open-label STARLIGHT clinical trial (NCT05417126) of MCO-010 in patients with advanced vision loss due to Stargardt disease. Six-month data from the clinical trial are expected in H1 2023.
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 Therapeutics is eligible for more frequent regulatory meetings and communications with the FDA.