Nanoscope Begins Rolling Submission of Biologics License Application for RP Gene Therapy

Nanoscope begins rolling submission of biologics license application for RP gene therapy

 Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene therapy to treat severe vision loss in retinitis pigmentosa, to the FDA, according to a press release.

Nanoscope Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for MCO-010, the First Gene-Agnostic Therapy to Treat Retinitis Pigmentosa

/PRNewswire/ -- Nanoscope Therapeutics Inc., a biotechnology company committed to developing and commercializing novel gene-agnostic therapies for patients...

Nanoscope Initiates Rolling Submission of BLA to FDA for MCO-010, the First Gene-Agnostic Therapy to Treat RP

Nanoscope Therapeutics announced the initiation of a rolling submission of a biologics license application (BLA) to the FDA for its lead investigational therapy, MCO-010, for the treatment of severe vision loss due to retinitis pigmentosa (RP). This marks a significant regulatory milestone as the first BLA submitted for a gene-agnostic gene therapy for retinal disease. According to Nanoscope, being gene-agnostic means that MCO-010 is designed to…

Nanoscope Therapeutics initiates rolling submission of BLA to FDA for MCO-010

MCO-010 is a gene-agnostic therapy for retinitis pigmentosa.

FDA grants Nanoscope rolling BLA submission of MCO-010

The completion of the full BLA submission is anticipated in early 2026 and is eligible for priority review under the program’s fast-track designation.