Healthcare Industry News:  fast track designation 

Regenerative Medicine Ophthalmology FDA

 News Release - January 30, 2023

Nanoscope Therapeutics Receives Fast Track Designation by the FDA for MCO-010 for the Treatment of Stargardt Disease

DALLAS, Jan. 30, 2023 -- (Healthcare Sales & Marketing Network) -- Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today 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 Stargardt disease to improve visual function.

"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 2 STARLIGHT clinical trial of MCO-010 therapy in Stargardt patients this quarter," said Sulagna Bhattacharya, CEO of Nanoscope. "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."

In September 2022, enrollment was completed in the Phase 2 open-label STARLIGHT clinical trial (NCT05417126) of MCO-010 in six patients with advanced vision loss due to a clinical or genetic diagnosis of Stargardt disease. In this study, all subjects received the same single intravitreal dose of 1.2E11gc/eye of MCO-010. Six-month data from the STARLIGHT trial are expected in Q1 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.

In February 2022, enrollment was completed in the Phase 2b multicenter, randomized, double-masked, sham-controlled RESTORE clinical trial (NCT04945772) of MCO-010. Top line data from the RESTORE trial are also expected in Q1 2023.

About Nanoscope Therapeutics Inc.
Nanoscope Therapeutics is developing gene-agnostic, sight restoring optogenetic therapies for the millions of patients blinded by retinal degenerative diseases, for which no cure exists. The company's lead asset, MCO-010, is presently in Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trials in the U.S. for retinitis pigmentosa (NCT04945772) with top-line data expected Q1 2023. The company has also fully enrolled a Phase 2 trial of MCO-010 therapy in Stargardt patients (NCT05417126). MCO-010 has received FDA fast track designation and FDA orphan drug designations for both RP and Stargardt. Preclinical assets include non-viral laser delivered MCO-020 gene therapy for geographic atrophy.


Source: Nanoscope Therapeutics

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