#USA #Dallas #Nanoscope Therapeutics #MOGENRY #Damon Daulerio

Nanoscope Therapeutics Welcomes Damon Daulerio as Executive Director of Regulatory Affairs

Nanoscope Therapeutics, a pioneering biotechnology company, has announced a strategic enhancement to its leadership team by appointing Damon Daulerio as the new Executive Director of Regulatory Affairs. This significant move comes at a critical juncture as the company seeks to advance its novel therapy MOGENRY® through the regulatory processes in major markets including the U.S. and Japan.

Damon Daulerio brings a wealth of experience to Nanoscope, having dedicated over 30 years to the pharmaceutical industry, with a robust focus in regulatory affairs spanning nearly three decades. Most recently, he served as Senior Director of Regulatory Affairs for Rare Diseases at Insmed, where he played a pivotal role in steering the company's global regulatory strategy while fostering communication with the FDA and other health authorities.

His expertise is particularly notable in the fields of ophthalmology and rare diseases, making him ideally suited to support Nanoscope's mission. At Novartis, as the Global Project Regulatory Director for Ophthalmology, Daulerio was instrumental in formulating regulatory strategies for products intended for global markets. His previous tenure at Alcon further solidified his capabilities, where he led initiatives supporting the registration and lifecycle management of existing ophthalmic products.

In his new role at Nanoscope Therapeutics, Daulerio will execute the company’s global regulatory strategy and engage in crucial discussions with health authorities as the company approaches the potential approval of MOGENRY. This innovative therapy is currently under review by regulators, including the FDA and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), marking an important milestone in Nanoscope's path toward bringing this breakthrough treatment to patients suffering from inherited retinal dystrophies (IRDs).

During the announcement, Sulagna Bhattacharya, Co-Founder and CEO of Nanoscope Therapeutics, expressed confidence in Daulerio’s capabilities, stating, "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. 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."

MOGENRY (sonpiretigene isteparvovec) represents a groundbreaking advancement in the treatment of retinitis pigmentosa, a condition characterized by severe vision loss. The therapy utilizes a unique optogenetic approach, delivering a genetically modified opsin to retinal cells, effectively transforming them into light-sensitive cells capable of responding to visual stimuli, even after the loss of photoreceptors. Notably, MOGENRY does not require genetic testing or invasive surgery, providing a feasible option for patients within standard retina office workflows.

As a leader in the space of vision restoration, Nanoscope Therapeutics continues to expand its clinical and regulatory momentum in preparation for the potential commercialization of MOGENRY. The FDA has accepted the Biologics License Application (BLA) for MOGENRY, while the company's Japan New Drug Application (JNDA) is currently under priority review by the PMDA. These developments underscore the company’s commitment to bringing innovative therapeutic options to individuals with retinal disorders.

Daulerio's addition to the team aligns with Nanoscope's strategic objectives as the company looks to build a robust regulatory foundation and enhance its presence in the global marketplace. With ongoing projects aimed at broader applications, including Stargardt disease and geographic atrophy, the organization is poised for continued growth and innovation in the field of vision restoration.

"Nanoscope has built a strong regulatory foundation for MOGENRY, with applications now under review in both the U.S. and Japan," Daulerio commented. "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. Our aim is to ensure that patients living with inherited retinal dystrophies can benefit from this transformative therapy."

As Nanoscope Therapeutics positions itself at the forefront of biotechnology, Daulerio’s extensive background serves as a catalyst for overcoming regulatory hurdles in the quest to improve vision for millions affected by retinal degeneration. The appointment is not only a strategic acquisition for the company but also a promising signal for the future of patient care in ophthalmology.

For further details about Nanoscope Therapeutics and its innovative therapies, visit Nanoscope Therapeutics.