Nanoscope plans to submit BLA for MCO-010

Texas, USA-based biotech Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025.

In connection with the meeting, the FDA acknowledged Nanoscope’s proposed next steps to facilitate a BLA submission for MCO-010 for the treatment of severe vision loss due to RP. Nanoscope outlined its plans for a rolling submission of the MCO-010 BLA for the treatment of severe vision loss due to RP based on its Fast Track designation.

“We are pleased with the positive interactions we have had with FDA as a result of the exceptional expertise and tireless commitment of the Nanoscope team,” said Sulagna Bhattacharya, co-founder and chief executive of Nanoscope.