- Global regulatory affairs leader with 30 years in the pharmaceutical industry, including 28 years in regulatory affairs spanning development, registration, and lifecycle management
- Most recently led FDA interactions as Senior Director, Regulatory Affairs (Rare Diseases) at Insmed; previously Global Project Regulatory Director, Ophthalmology at Novartis
- Appointment strengthens regulatory leadership as MOGENRY® advances through FDA review of its Biologics License Application and PDMA priority review of the Japan New Drug Application
DALLAS, Nov. 5, 2026 /PRNewswire/ — Nanoscope Therapeutics Inc., a biotechnology company committed to developing and commercializing novel, disease-agnostic therapies for patients with photoreceptor loss and vision impairment due to retinal degeneration, today announced the appointment of Damon Daulerio, MBA, as Executive Director of Regulatory Affairs. Mr. Daulerio will execute on Nanoscope’s global regulatory strategy and participate in interactions with health authorities as the company advances toward the potential approval and launch of MOGENRY® (sonpiretigene isteparvovec; MCO-010).
Mr. Daulerio brings 30 years of pharmaceutical industry experience, including 28 years in regulatory affairs, with particular depth in ophthalmology and rare diseases. Most recently, he served as Senior Director, Regulatory Affairs (Rare Diseases) at Insmed Incorporated, where he developed and executed global regulatory strategy, served as the company’s primary FDA liaison, led all FDA meetings, and participated in meetings with the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Previously, he spent nearly six years at Novartis as Global Project Regulatory Director, Ophthalmology, leading regulatory strategy for globally marketed products and U.S. development programs. Before that, he served as Head of Product Support Pharma, Global Regulatory Affairs at Alcon, where he led a team supporting new product registrations and lifecycle maintenance for approved ophthalmic drug products worldwide.
Earlier in his career, Mr. Daulerio served as Director of Regulatory Affairs at Neos Therapeutics and spent eight years in regulatory affairs at Boehringer Ingelheim Pharmaceuticals. There he guided a product from pre-IND through New Drug Application submission, leading all FDA meetings and co-leading the product’s FDA Pulmonary-Allergy Drugs Advisory Committee meeting; the FDA subsequently approved the product. He began his career at Purdue Pharma and Eisai Medical Research in global regulatory and clinical data roles, including an international assignment with Napp Pharmaceuticals in Cambridge, U.K. Mr. Daulerio holds an MBA in International Business and a B.S. in Biology from Fairfield University.
“With MOGENRY now under review by regulators in both the U.S. and Japan, regulatory execution is the critical path to bringing this therapy to patients,” said Sulagna Bhattacharya, Co-Founder and Chief Executive Officer of Nanoscope Therapeutics. “Damon has taken a product from pre-IND through NDA submission and an FDA advisory committee, and he has spent much of his career in ophthalmology at Novartis and Alcon, as well as rare disease at Insmed. His hands-on experience with the FDA, EMA, and PMDA is exactly what we need as we move through review and toward potential approval in multiple markets.”
Nanoscope continues to build clinical, regulatory, manufacturing, and commercial readiness momentum in support of MOGENRY for inherited retinal dystrophies (IRDs). The FDA has accepted for review the company’s Biologics License Application (BLA) for MOGENRY for the treatment of retinitis pigmentosa (RP) with severe vision loss,. A Japan New Drug Application (JNDA) for MOGENRY is also currently under PMDA review for IRDs. These milestones reflect Nanoscope’s expanding global regulatory pathway as it prepares for commercialization in key markets.
“Nanoscope has built a strong regulatory foundation for MOGENRY, with applications now under review in both the U.S. and Japan,” said Mr. Daulerio. “My focus will be on working closely with the FDA, PMDA, and other health authorities through review, and on executing the global regulatory strategy that supports MOGENRY across indications and markets, so that patients living with inherited retinal dystrophies can benefit from this therapy.”
About MOGENRY (sonpiretigene isteparvovec; MCO-010)
Nanoscope’s multi-characteristic opsin (MCO) technology utilizes a proprietary genetically engineered synthetic opsin to enable optimized performance in terms of high light sensitivity across a broad spectrum and fast kinetics. After Nanoscope’s Co-Founder, President, and Chief Scientific Officer, Samarendra Mohanty, envisioned and invented the technology, his team spent more than a decade evaluating its performance across multiple animal models and human diseases. MOGENRY is an investigational, one-time, in-office, intravitreal optogenetic gene therapy built on Nanoscope’s MCO platform. By delivering a multi-characteristic opsin gene to the highly dense bipolar retinal cells, MOGENRY makes these surviving cells directly light-sensitive, enabling them to utilize the remaining visual circuitry following photoreceptor loss. MOGENRY does not require genetic testing, invasive surgery, or repeat dosing, and is designed for administration within existing retina office workflows.
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 RP (NCT04945772), the FDA has accepted and filed the company’s BLA for MOGENRY, and the PMDA has accepted for priority review the company’s Japan new drug application (JNDA) for MOGENRY for the treatment of IRDs. If approved, MOGENRY has the potential to become the standard of care for patients with RP and other IRDs, 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 (NCT05417126) of MCO-010 in Stargardt disease (SD) and plans to initiate a Phase 3 registrational trial in the near future. MCO-010 has received FDA Fast Track and Orphan Drug designations for both RP and SD, along with Regenerative Medicine Advanced Therapy (RMAT) designation for SD, and European Medicines Agency (EMA) Orphan designations covering non-syndromic and syndromic rod- and cone-dominant dystrophies, as well as macular dystrophies. MCO-010 has also received Sakigake and Orphan designations for IRDs in Japan and an Orphan designation for IRDs in Saudi Arabia. A Phase 2 program for MCO in geographic atrophy is expected to initiate in the near future, and other investigational new drug (IND)-ready programs include Leber congenital amaurosis (LCA). Learn more at NanosTherapeutics.com and follow @NSTherapeutics on X and on LinkedIn.
Contact:
Nanoscope Therapeutics Inc.
+1 (817) 857-1186
PR@nanostherapeutics.com
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SOURCE Nanoscope Therapeutics
