Dompé announced the first patient has been dosed in the United States in a phase 3 study of cenegermin-bkbj ophthalmic solution for the treatment of persistent corneal epithelial defect (PCED). The phase 3 trial, Orunea, is a multicenter, randomized, double-masked study comparing cenegermin-bkbj against placebo in achieving complete healing of PCED, the company said in a press release.

According to Dompé, the study will enroll approximately 150 people with PCED aged 18 years and above and the primary endpoint will assess the proportion of responders achieving complete epithelial healing of the cornea.

Cenegermin-bkbj is an investigational product for PCED, and its safety and efficacy for this indication have not been established or approved by any regulatory authority.