Dompé’s cenegermin selected by FDA for new national priority review program
The U.S. Food and Drug Administration has selected cenegermin, developed by Dompé, as 1 of 9 therapies to receive a Commissioner’s National Priority Voucher (CNPV), a new program that accelerates review of products addressing significant unmet medical needs.
Cenegermin (Oxervate), the first FDA-approved therapy for neurotrophic keratitis, was recognized for its potential to advance treatment in sight-threatening disease. Dompé plans to use the voucher to support a Biologics License Application for an intranasal formulation of nerve growth factor (cenegermin-bkbj) for non-arteritic anterior ischemic optic neuropathy (NAION), a leading cause of sudden optic nerve-related vision loss.
“The CNPV is a strategic lever to accelerate access to transformative therapies for patients with unmet medical needs such as NAION,” said Sergio Dompé, Executive President of Dompé. “Building on our breakthrough with Oxervate, we are now advancing a novel intranasal NGF formulation designed to bypass the blood-brain barrier and open new possibilities in neuro-ophthalmology.”
The voucher provides priority FDA review within 1–2 months of application filing, along with enhanced communication during development. Additional CNPV recipients will be announced later this year.
