Key Takeaways

  • Dompé has dosed the first US patient in the phase 3 Orunea trial evaluating cenegermin-bkbj for persistent corneal epithelial defect
  • The randomized, double-masked study will enroll approximately 150 patients and assess whether the recombinant human nerve growth factor therapy can achieve complete corneal epithelial healing compared with placebo

Dompé has announced that the first patient in the United States has been dosed in the phase 3 Orunea clinical trial evaluating cenegermin-bkbj ophthalmic solution for the treatment of persistent corneal epithelial defect (PCED).

The multicenter, randomized, double-masked study is designed to compare cenegermin-bkbj with placebo in achieving complete healing of persistent corneal epithelial defects. The trial marks the latest expansion of Dompé's research program focused on recombinant human nerve growth factor (rhNGF), building on the company's experience in neurotrophic keratitis.

The phase 3 Orunea study is expected to enroll approximately 150 adults aged 18 years and older with PCED. The primary endpoint will assess the proportion of patients achieving complete epithelial healing of the cornea. According to Dompé, the trial is designed to evaluate whether targeting the biological mechanisms involved in epithelial repair can improve outcomes in patients whose corneal healing processes have been compromised.

"Advancing cenegermin-bkbj into a phase 3 program for PCED reflects the strength of the underlying science and the consistency of the rhNGF mechanism across corneal pathologies characterized by impaired healing," said Marcello Allegretti, Chief Scientific Officer at Dompé. "This study is designed to rigorously evaluate whether targeting the biological drivers of epithelial repair can offer a clinically meaningful benefit for patients with limited therapeutic options."

PCED occurs when the corneal epithelium fails to heal following injury or disease, leaving a persistent defect that remains unhealed for more than 2 weeks despite standard treatment. The condition can cause significant ocular pain, blurred vision, and increased risk of infection. If untreated, PCED may progress to severe corneal complications, including permanent scarring and partial or complete vision loss.

Cenegermin-bkbj remains investigational for the treatment of PCED, and its safety and efficacy for this indication have not been established by regulatory authorities.

Additional information about the Orunea trial is available on ClinicalTrials.gov under identifier NCT07519902.