DALLAS, July 7, 2026 — Catalent, the leader in enabling the development and supply of better treatments for patients worldwide, and Terapéutica del nanoscopio, a biotechnology company committed to commercializing novel, disease-agnostic, vision-restoring therapies for patients with photoreceptor loss due to retinal degenerations, 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.
Acerca de Nanoscope Therapeutics
Terapéutica del nanoscopio 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), se ha iniciado una presentación continua de BLA a la FDA. Si se aprueba, MCO-010 tiene el potencial de ser el tratamiento estándar para pacientes con RP, administrado como una inyección única en el consultorio sin necesidad de pruebas genéticas. La compañía también ha mostrado resultados prometedores en el ensayo clínico de fase 2 STARLIGHT de MCO-010 en la enfermedad de Stargardt (SD) (NCT05417126) y planea iniciar una Ensayo de registro de fase 3 En 2026, MCO-010 recibió las designaciones de vía rápida y medicamento huérfano de la FDA para RP y SD, junto con la designación RMAT para SD, así como las designaciones Sakigake y huérfana de la PMDA para distrofias retinianas hereditarias (IRD) y las designaciones huérfana de la EMA y la SFDA para IRD. Se espera que un programa de fase 2 para MCO en atrofia geográfica (GA) comience en 2026. Otros programas listos para IND incluyen la amaurosis congénita de Leber (LCA).
Contacto:
Catalent
media@catalent.com
Nanoscope Therapeutics, Inc
+1 (817) 857-1186
PR@nanostherapeutics.com
FUENTE Terapéutica del Nanoscopio