Dompé has enrolled the first patient in a phase 2b clinical trial of its recombinant human nerve growth factor eye solution for the treatment of dry eye disease, according to a press release.
NGF0118 study will evaluate the safety and efficacy of rhNGF in approximately 300 moderate to severe dry eye patients at 11 U.S. sites, the release said.
"The effects of currently available treatments for chronic dry eye disease mostly address only inflammation and wear off soon after discontinuing therapy. Our researchers have decades of understanding of the mechanism of action of nerve growth factor, and this knowledge gives us hope that a new therapy, which includes rhNGF, could produce a more durable treatment effect,” Dompé chief medical officer Flavio Mantelli, MD, PhD, said. “Our aim is to potentially free some patients from the burden of continuous treatment.”
Patients will undergo 4 weeks of treatment followed by 12 weeks of observation. Change in ocular surface tear wetting as measured by Schirmer’s test is the primary endpoint.