Cenegermin Eye Drops, First Therapy for Neurotrophic Keratitis, Nears Approval in China

Text | Baihuawen

On August 11, the marketing application for Cenegermin eye drops submitted by Dompé Farmaceutici in China entered the administrative approval phase, with expectations of imminent approval for the treatment of neurotrophic keratitis.

Neurotrophic KeratitisNeurotrophic keratitis is a rare disorder characterized by impaired corneal epithelial healing. It is marked by compromised corneal sensation, leading to extensive corneal epithelial defects and ulcers; severe progression of these ulcers can result in corneal perforation. The prevalence of this disease is less than 5 per 10,000. Currently, there are no effective treatment options available in China.

Cenegermin is a novel recombinant human nerve growth factor that was designated as an orphan drug by the European Union on December 14, 2015. It was approved in the European Union in July 2017 and in the United States in August 2018, becoming the first FDA-approved therapy for neurotrophic keratitis.

In two randomized, double-blind, multicenter clinical trials, a total of 151 patients were enrolled. The NGF0214 study included patients with unilateral eye injury, while the other study included patients with bilateral eye injury. Follow-up results at 8 weeks showed that the proportion of corneal healing in patients treated with Cenegermin was higher than that in patients treated with placebo.

In China, cenegermin eye drops were included in the "First Batch of Clinically Urgent Overseas Drugs" in August 2018. In June 2019, Dompé Farmaceutici submitted a marketing application for this drug in China.