Nanoscope Therapeutics

09/02/2025

Today, we at Nanoscope Therapeutics Inc. are proud to share important global regulatory updates for our lead disease-agnostic optogenetic therapy, MCO-010:

🌐 European Medicines Agency grants MCO-010 five Orphan designations across a wide spectrum of retinal diseases involving photoreceptor loss, including syndromic and non-syndromic, rod- and cone-dominant, and macular dystrophies.

🌐 The US Food and Drug Administration (FDA) grants MCO-010 Regenerative Medicine Advanced Therapy (RMAT) designation, in addition to current Orphan Drug and Fast Track designations, for Stargardt disease (SD).

👁️ These recognitions strengthen global regulatory pathways for MCO-010 and bring us closer to delivering a therapy with the potential to restore vision for people living with retinal degenerative diseases.

Our vision-improving clinical programs are advancing globally, with positive Phase 2b/3 RESTORE results shown in patients with retinitis pigmentosa and encouraging findings seen in the Phase 2 STARLIGHT trial in patients with SD. A Phase 3 registrational trial in patients with SD and a Phase 2 trial in patients with geographic atrophy from advanced age-related macular degeneration are expected to begin by the end of 2025.

To read the full press release: https://lnkd.in/gkhKpFD8
To learn more about Nanoscope and MCO-010 visit our website: nanostherapeutics.com

08/26/2025

Members of the Nanoscope Visionary Advisory Committee will present exciting data from our 3-year REMAIN trial at the upcoming 2025 Euretina Congress and The Retina Society Annual Scientific Meeting. These talks will highlight efficacy, durability, and safety of Nanoscope’s MCO (multi-characteristic opsin) optogenetic therapy platform.

❝Durable efficacy and long-term tolerability are meaningful for patients suffering from irreversible, progressive vision loss due to RP, and underscore the potential of MCO-010 to redefine the standard of care for these patients.”, said Dr. Samarendra Mohanty, President and Chief Scientific Officer, Nanoscope. “It is an exciting time at Nanoscope as we prepare MCO-010 for commercialization, kicked off by the recent initiation of our rolling BLA with the FDA.❞

Details of the presentations:

👁️ 2025 Euretina Congress, Paris, France:
Presentation Title: REMAIN: 152-Week Extended Analysis From the RESTORE Study of MCO-010 Optogenetic Therapy for Retinitis Pigmentosa
Session Title: Free Paper 11- Inherited Retinal Diseases
Session Date: Friday, September 5
Session Time: 5:24 pm CET
Presenter: Jordi Monés MD PhD; Director, Institut de la Macula, Barcelona, Spain

👁️2025 Retina Society Annual Meeting, Chicago, Illinois, USA: Presentation Title: REMAIN: 152-Week Extended Analysis from the MCO-010 Optogenetic Therapy for Retinitis Pigmentosa RESTORE Study
Session Title: Genetic Diseases, Dystrophies, Degenerations
Session Date: Wednesday, September 10
Session Time: 3:44 pm CDT
Presenter: Christine Kay, MD; Vitreoretinal Associates, Director of Clinical Research and Retinal Genetics

07/28/2025

https://nanostherapeutics.com/2025/07/28/nanoscope-therapeutics-data-to-be-presented-at-2025-american-society-of-retina-specialists-annual-scientific-meeting/

07/22/2025

We’re proud to share that a new peer-reviewed paper from the Nanoscope Therapeutics Research team has been published in Advanced Therapeutics.

The paper highlights Nanoscope’s groundbreaking research that supports the company's lead asset therapy, MCO-010, and its potential to help restore vision in people living with retinal degenerative diseases.

Congratulations to our brilliant scientific Pre-Clinical R&D Team, led by our President and Chief Scientific Officer, Dr Samarendra Mohanty, who are pushing the boundaries of what’s possible to bring back the light of hope to patients.

Read the full press release here: https://nanostherapeutics.com/2025/07/22/nanoscope-therapeutics-publishes-mechanism-of-action-details-for-proprietary-broadband-and-fast-multi-characteristic-opsin-technology/

Read the paper here: https://advanced.onlinelibrary.wiley.com/doi/10.1002/adtp.202500009

07/14/2025

❤️ To the patients and families we work for — we see you! And today, we are proud to announce the initiation of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for our lead investigational therapy, MCO-010, for the treatment of severe vision loss due to retinitis pigmentosa (RP). We thank the FDA for their guidance and all our clinical trial patients as we aim to bring back the light of hope to RP patients.

This marks a significant regulatory milestone as the first BLA submitted for a gene-agnostic gene therapy for retinal disease. Being gene-agnostic means that MCO-010 is designed to address the broad genetic diversity of RP—a condition linked to over 100 known genes and more than 1,000 different mutations—regardless of the underlying mutation.

Highlights:
🔷 First modules of BLA submitted to FDA under rolling review, with full submission anticipated in early 2026
🔷 MCO-010 BLA for RP is eligible for priority review based on fast-track designation
🔷 If approved, MCO-010 has the potential to be the standard of care for RP, delivered via a one-time, in-office intravitreal injection with the ability to restore vision in patients with severe vision loss regardless of their underlying genetic mutation

👉Read the full press release here: https://nanostherapeutics.com/2025/07/14/nanoscope-therapeutics-initiates-rolling-submission-of-biologics-license-application-to-fda-for-mco-010-the-first-gene-agnostic-therapy-to-treat-retinitis-pigmentosa/
👉For more information on MCO-010 and Nanoscope Therapeutics visit Nanostherapeutics.com

05/01/2025

Congratulations Dr. Batabyal on this recognition of your groundbreaking research.

Nanoscope Director of Nonclinical Development, Dr. Subrata Batabyal, Recognized for Pioneering Work in Optogenetic Vision Restoration Batabyal receives 2025 Carl Camras Translational Research Award from ARVO Foundation DALLAS, May 1, 2025 — Nanoscope Therapeutics Inc., a biotechnology company comm...

03/27/2025

We are thrilled to welcome Ashish Patel PhD MBA to Nanoscope Therapeutics as our Senior Vice President, Sales & Marketing. Dr. Patel is a recognized leader with proven results across brand, sales and research and development management for some of the world’s most recognized startup biotech and pharmaceutical organizations.

“With his unique blend of scientific and commercial expertise, particularly in the treatment of retinal diseases, Dr. Patel is well-equipped to drive Nanoscope’s sales and marketing strategy as we move towards commercialization of our optogenetic therapies,” said Sulagna Bhattacharya, co-founder and CEO of Nanoscope Therapeutics Inc.

Dr. Patel has extensive experience in aligning scientific and commercial insights to inform strategic and business decisions with a focus on patients. Most recently, he served as Vice President of Sales for Iveric Bio (now Astellas), launching IZERVAY™, a treatment for geographic atrophy. Prior to Iveric, Dr. Patel spearheaded marketing and launch efforts for Novartis’ BEOVU®, used to treat chronic eye conditions, including wet age-related macular degeneration (AMD). His tenure at Bayer spanned over a decade, during which he held multiple brand, sales and research management roles. Notably, he served as the global launch lead for the fastest-growing indication within Bayer’s blockbuster EYLEA® retina business. He began his career as a senior research and development scientist with Novartis.

Join us in welcoming Dr. Patel to the Nanoscope team!

For more information: read the full Press Release:
https://lnkd.in/gc7KCxhttps://nanostherapeutics.com/2025/03/27/ashish-patel-phd-joins-nanoscope-as-senior-vice-president-of-sales-and-marketing/

03/20/2025

We are thrilled to welcome Ademola Daramola, D.Sc, to Nanoscope Therapeutics Inc. as our new Vice President of Quality and Compliance!

“Ademola is an accomplished leader in quality assurance and compliance across different functions, with deep experience in the pharmaceutical industry, including with the FDA,” said Sulagna Bhattacharya, co-founder and CEO of Nanoscope. “His expertise will be invaluable as we advance toward commercialization of our optogenetic therapies.”

Please join us in congratulating and welcoming Dr. Daramola to the Nanoscope team! We look forward to his contributions as we continue on our mission to restore vision in blind patients in real-world settings by developing and commercializing novel gene therapies for retinal degenerative diseases, for which no treatment currently exists.

For more information read the complete press release on our website: nanostherapeutics.com.

03/05/2025

Nanoscope is extremely proud to announce that Ramesh Arjunji, PhD, has joined our team as EVP of Value and Access. Dr. Arjunji brings a breadth of experience including commercialization, R&D, medical affairs and business development gained from various leadership positions in the biopharmaceutical industry. We are excited to have his expertise and passion on our team.

“In addition to his diverse industry experience spanning ophthalmology, neurology, oncology, immunology and medical devices, Ramesh has been an important market access leader for some of the most successfully commercialized gene therapies. We look forward to his contributions as we make preparations to launch MCO-010 as the first restorative treatment for retinitis pigmentosa patients,” said Sulagna Bhattacharya, Co-Founder and CEO of Nanoscope Therapeutics Inc.
To learn more about Nanoscope and Dr. Arjunji read the full release: https://bit.ly/4h8FbwX