Dompé's NAION program selected for FDA Commissioner’s National Priority Voucher Program

Dompé was selected by the US Food and Drug Administration (FDA) to participate in the Commissioner’s National Priority Voucher (CNPV) program. Because of this selection, Dompé has received a voucher granting a significantly shortened review timeline for marketing applications and enhanced collaboration with the FDA.¹

The CNPV program was announced by the FDA in June 2025 and offers companies the opportunity to reduce standard application review times from 10–12 months to just 1–2 months through a collaborative, multidisciplinary review process. The organization does, however, state that if necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, manufacturing violations are present, or as they otherwise deem appropriate.²

Marty Makary, MD, MPH, FDA Commissioner, commented on the program, saying, “One of our core goals is to deliver more cures and meaningful treatments—especially ones that have an outsized impact on our most pressing national priorities. We must modernize the review process and try new approaches to meet the needs of the American people.”

According to the company, it intends to apply the voucher to the Biologic License Application (BLA) for an intranasally administered formulation of nerve growth factor (Cenegermin-bkbj) for the treatment of non-arteritic anterior ischemic optic neuropathy (NAION). The company states that intranasal administration of NGF is a “novel approach, patented by Dompé, offering a non-invasive delivery method.”¹

Sergio Dompé, executive president at Dompé commented on the program, saying, “The CNPV represents a strategic lever to accelerate access to transformative therapies for patients with unmet medical needs as NAION. Building on our pioneering achievement with Oxervate—the first NGF-based therapy approved for Neurotrophic Keratitis in 2018—we are now advancing a novel, intranasal formulation of NGF (Cenegermin-bkbj) to bypass the blood-brain barrier and redefine possibilities in neuro-ophthalmology.”

There are currently no approved treatments to reverse vision loss or prevent worsening in patients with NAION.

According to the company, a registrational pivotal trial program is planned in more than 130 sites across 16 countries.¹

Nine voucher recipients and drugs were chosen in the first-ever selections in the program. Dompé’s cenegermin-bkbj was the only one in the eye care area. Other recipients included:²

• Pergoveris for infertility
• Teplizumab for Type I diabetes
• Cytisinicline for nicotine vaping addiction
• DB-OTO for deafness
• RMC-6236 for pancreatic cancer
• Bitopertin for porphyria
• Ketamine for domestic manufacturing of a critical drug for general anesthesia
• Augmentin XR for domestic manufacturing of a common antibiotic

The FDA stated it plans to announce another group of CNPV recipients in the coming months.²

References:

1. Dompé's program in NAION selected for Landmark FDA Commissioner’s National Priority Voucher Program. Published October 16, 2025. Accessed October 20, 2025. https://www.dompe.com/us/media/press-releases/dompe-s-program-in-naion-selected-for-landmark-fda-commissioner-s-national-priority-voucher-program/

2. FDA Awards First-Ever National Priority Vouchers to Nine Sponsors. Published October 16, 2025. Accessed October 20, 2025. https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors