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news.Nanoscope Therapeutics has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) for the treatment of Stargardt disease to improve visual function.
The firm expects to receive the six-month data from the STARLIGHT trial in Q1 2022. Credit: Paul Diaconu from Pixabay.
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The optogenetic monotherapy has been developed to restore vision in blind patients.
Nanoscope CEO Sulagna Bhattacharya said: “We are pleased to receive the FDA’s decision to grant Fast Track Designation for the second indication of our vision restoring therapy, and we look forward to sharing six-month data from the Phase II STARLIGHT clinical trial of MCO-010 therapy in Stargardt patients this quarter.
“Receiving Fast Track Designation reinforces the urgency of our mission to find an effective solution for Stargardt patients and is an acknowledgement of MCO-010’s potential to address this unmet medical need.”
The FDA’s Fast Track designation will help accelerate the development and advance the review of new therapies for the treatment of serious conditions with unmet medical need.
The latest designation authorises Nanoscope for more frequent regulatory meetings and communications with the FDA.
Nanoscope has completed the Phase II open-label STARLIGHT clinical trial (NCT05417126) enrolment in September last year for MCO-010 in six patients with advanced vision loss due to a clinical or genetic diagnosis of Stargardt disease.
All these patients were given the same single intravitreal dose of 1.2E11gc/eye of MCO-010.
The firm expects to receive the six-month data from the STARLIGHT trial in the first quarter of this year.
In February, the company completed enrolment in the Phase IIb multicentre, randomised, double-masked, sham-controlled RESTORE clinical trial (NCT04945772) of the therapy.
Nanoscope expects to receive top line data from the RESTORE trial in the same quarter.
