Dallas-based Nanoscope Therapeutics, a late-stage clinical biotechnology company developing gene therapies for inherited retinal diseases and age-related macular degenerations, has named Paul Hallen as its new chief operating officer.

As COO, Hallen will oversee Nanoscope’s global operations, including commercial readiness, supply chain, and cross-functional execution, as the company works toward regulatory approval and launch of MCO-010 (MOGENRY), a therapy developed to treat retinitis pigmentosa.

“Paul is a highly respected ophthalmology leader with a rare combination of technical, operational, and commercial expertise,” said Sulagna Bhattacharya, co-founder and CEO of Nanoscope.

“We have known and closely interacted with Paul for many years,” she added in a statement, “and his appointment comes at an important time as we continue preparing for the potential commercialization of MOGENRY. His experience across retina, product development, and global launch planning will be invaluable as we work to bring our vision-restoring therapies to patients worldwide.”

Hallen has more than three decades of ophthalmic leadership experience that includes marketing, sales, manufacturing, quality, research and development, and business strategy. Previously, he served as VP and global head of retina at Alcon, where he helped lead one of the industry’s premier retina franchises, and also served as vice president of R&D supporting internal development and external acquisition activities in Alcon’s business units. Hallen also has been a board member of US Retina.

“I’m excited to join Nanoscope at such an important stage in its development,” Hallen said. “Nanoscope’s MOGENRY platform represents a fundamentally differentiated approach with the potential to restore vision for patients with severe retinal disease. I look forward to working with the team to help advance MOGENRY toward potential approval and to support the company’s operational and commercial readiness for the next stage of growth.”

Preparing for commercialization

Nanoscope said it continues to build clinical, regulatory, and manufacturing momentum in support of MOGENRY for retinitis pigmentosa, including advancement of its rolling Biologics License Application in the United States.

The company is also building a global regulatory foundation for MOGENRY, with Orphan Drug, Fast Track, and RMAT designations in the United States, Sakigake and Orphan Drug designations in Japan, five EMA Orphan designations for inherited retinal dystrophies, and, most recently, an Orphan drug designation for IRDs in Saudi Arabia. The company said that these milestones highlight an expanding international regulatory pathway as it advances commercialization planning across key global markets.

MCO is a one-time, in-office, intravitreal disease-agnostic therapy platform designed to restore vision in patients with photoreceptor degeneration, including Retinitis Pigmentosa (RP), Stargardt disease (SD), and geographic atrophy (GA). By activating highly dense bipolar retinal cells to become light sensitive, MCO utilizes the remaining visual circuitry following photoreceptor death. MCO treatment does not require genetic testing, invasive surgery, or repeat dosing, allowing for broad patient applicability within existing retina office workflows, Nanoscope said.

Don’t miss what’s next. Subscribe to Dallas Innovates.

Track Dallas-Fort Worth’s business and innovation landscape with our curated news in your inbox Tuesday-Thursday.