- Catalent has expanded its partnership with Nanoscope Therapeutics to provide commercial-compliant packaging, distribution, and packaging validation services for the optogenetic gene therapy MCO-010.
- The expanded agreement supports Nanoscope’s Biologics License Application (BLA), with a rolling submission currently underway with the U.S. Food and Drug Administration (FDA).
Catalent has expanded its partnership with Nanoscope Therapeutics to support the late-phase clinical and commercial supply of MCO-010, the biotechnology company’s lead optogenetic gene therapy for patients with photoreceptor loss caused by retinal degeneration. Under the expanded agreement, the CDMO will provide commercial-compliant packaging and distribution services and has secured the commercial packaging validation program to support Nanoscope’s Biologics License Application (BLA). A rolling submission to the U.S. Food and Drug Administration (FDA) is currently underway.
The expanded collaboration builds on the companies’ existing relationship as MCO-010 advances toward potential commercialization. According to the announcement, Catalent will support packaging and distribution activities required for commercial readiness while helping Nanoscope prepare for regulatory review.
“Catalent is pleased to expand our collaboration with Nanoscope as MCO-010 advances toward potential commercialization. Catalent is committed to supporting Nanoscope at every stage of the journey to bring this innovative therapy to the market and help make Nanoscope’s mission of vision restoration a reality for patients around the globe.”
Ricky Hopson, Group President, Clinical & Specialty Services and Chief of Staff at Catalent
Nanoscope said the expanded partnership will support the continued contract manufacturing and commercialization of MCO-010. The company stated that a packaging partner capable of scaling for global commercialization is an important part of its commercial strategy as it continues manufacturing the therapy’s commercial drug product.
MCO-010 is being developed to restore vision in patients with advanced retinal degenerative diseases, including retinitis pigmentosa and Stargardt disease, by reprogramming retinal cells to become light-sensitive. The therapy is intended for patients with late-stage disease who currently have limited therapeutic treatment options.
