Catalent and Nanoscope Therapeutics Expand Partnership to Support Late-Phase Development and Commercial Supply of MCO-010

TAMPA, Fla. & DALLAS--(BUSINESS WIRE)--Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, and Nanoscope Therapeutics, a biotechnology company committed to commercializing novel, disease-agnostic, vision-restoring therapies for patients with photoreceptor loss due to retinal degeneration, today announced an expanded partnership to support late-phase clinical and commercial supply of Nanoscope's lead optogenetic gene therapy, MCO-010.

Under the expanded partnership, Catalent will provide commercial-compliant packaging and distribution for MCO-010 and has secured the commercial packaging validation program to support Nanoscope's Biologics License Application (BLA). A rolling submission with the U.S. Food and Drug Administration (FDA) is currently underway.

"Catalent is pleased to expand our collaboration with Nanoscope as MCO-010 advances toward potential commercialization," said Ricky Hopson, Group President, Clinical & Specialty Services and Chief of Staff. "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."

"As we continue to manufacture MCO-010 commercial drug product, having a packaging partner who can scale with us to meet the needs of global commercialization is essential," said Sulagna Bhattacharya, Co-Founder and CEO of Nanoscope Therapeutics. "Catalent's expertise and reliability give us confidence as we prepare for the next stage of this journey, and we look forward to continuing this partnership as we work to bring a much-needed treatment option to patients living with retinal degenerative diseases."

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. This approach is designed to treat patients with late-stage disease who currently have limited therapeutic options.

About Catalent

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) championing the missions that help people live better and healthier lives. Every product that Catalent helps develop, manufacture and launch reflects its commitment to improve health outcomes around the world through its Patient First approach. Catalent provides unparalleled service to pharma, biotech and consumer health customers, delivering on their missions to transform lives. Catalent tailors end-to-end solutions to meet customers' needs in all phases of development and manufacturing. With thousands of scientists and technicians and the latest technology platforms at nearly 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.

About Nanoscope Therapeutics

Nanoscope Therapeutics is developing disease-agnostic, vision-restoring optogenetic therapy for millions of patients blinded by retinal degenerative diseases. Following positive results from the RESTORE Phase 2b/3 multicenter, randomized, double-masked, sham-controlled clinical trial for retinitis pigmentosa (RP) (NCT04945772), a rolling BLA submission to the FDA has been initiated. If approved, MCO-010 has the potential to be the standard of care for RP patients, administered as a one-time, in-office injection without the need for genetic testing. The company has also shown promising results in the STARLIGHT Phase 2 clinical trial of MCO-010 in Stargardt disease (SD) (NCT05417126) and plans to initiate a Phase 3 registrational trial in 2026. MCO-010 has received FDA Fast Track and Orphan Drug designations for both RP and SD, along with RMAT designation for SD, as well as PMDA Sakigake and Orphan designations for inherited retinal dystrophies (IRDs) and EMA, SFDA Orphan designations for IRDs. A Phase 2 program for MCO in geographic atrophy (GA) is expected to start in 2026. Other IND-ready programs include Leber congenital amaurosis (LCA).