Milan-based biotech firm Dompé has revealed that the FDA has awarded approval in the US to its Oxervate (cenegermin-bkbj ophthalmic solution) product in the treatment of neurotrophic keratitis (NK).

The decision was based on data derived from the largest combined population randomised clinical trial of NK patients, showing that 72% of Oxervate patients were completely healed after eight weeks in one study, and 65.2% in another. One year after the former study, 80% of healed patients remained healed.

NK is rare, progressive disease of the eye caused by infection or surface damage to the eye that can lead to corneal scarring and vision loss. If left untreated, the condition can become more ever-more severe, leading to persistent epithelial defects, corneal ulcers, melting and perforation. It affects around 65,000 in the US.

"Neurotrophic keratitis can be disabling, hard to treat, and many patients do not respond well to existing therapies," said Reza Dana, Professor of Ophthalmology at Harvard Medical School, Director of the Cornea Service, Senior Scientist at the Massachusetts Eye and Ear, and Dompé medical advisor. "By directly promoting corneal healing, Oxervate has the potential to change the way neurotrophic keratitis is treated, and may eventually result in a new standard of care for patients with this rare condition."

Sergio Dompé, Chairman of Dompé, added: "Oxervate represents the first therapy from Dompé that will be available in the United States. We are dedicated to delivering this important treatment to people living with neurotrophic keratitis and are grateful to the patients and physicians who participated in clinical trials and enabled this advancement."

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