Dompé Doses First Patient in Phase 3 Study of Cenegermin-bkbj in PCED
Affecting fewer than 200,000 people in the U.S., persistent corneal epithelial defect (PCED) is a rare condition with a high unmet clinical need, as current treatment options remain limited.
PCED occurs when the corneal surface fails to heal despite standard treatment and remains open or damaged for more than two weeks.
The Phase 3 trial, named “Orunea,” will enroll 150 adult patients to evaluate whether Cenegermin-bkbj — a recombinant human Nerve Growth Factor (rhNGF) — can achieve complete epithelial healing of the cornea.
Dompé, a leading biopharmaceutical company with operations in Italy and the U.S., announced the first patient has been dosed in the US 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.
