Nanoscope Therapeutics today announced it will submit a biologics license application (BLA) to the US Food and Drug Administration (FDA) for MCO-010, an intravitreal treatment for severe vision loss caused by retinitis pigmentosa (RP). The company said in a press release that it expects to submit the BLA in the first quarter of 2025.
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In the October issue of Retinal Physician, Yasha Modi, MD, discussed the potential of MCO-010 and optogenetic therapy with Nanoscope Therapeutics cofounder and CEO Sulagna Bhattacharya and the company’s chief medical advisor Allen C. Ho, MD, FACS, FASRS. Read more here.
MCO-010 is a multicharacteristic opsin, delivered by an adeno-associated virus (AAV2) in a single intravitreal injection, that has been shown in clinical trials to affect bipolar and retinal ganglion cells within the retina, sensitizing the bipolar cells to detect ambient light and transmit signals to the brain through residual neurons. This can preserve and even restore vision, even when photoreceptors are no longer functioning. Topline data from the phase 2b RESTORE trial of MCO-010 for patients with advanced RP, which was completed earlier this year, showed clinically meaningful vision improvement in legally blind individuals with progressive and permanent neurodegeneration of the retina. MCO-010 has received both orphan drug and fast track designations from the FDA, and is also being studied as a treatment for Stargardt disease and geographic atrophy.