Italian biopharmaceutical company Dompé has received the go-ahead for Oxervate (cenegermin) for the treatment of moderate-to-severe neurotrophic keratitis (NK), a rare eye disease that affects less than five out of every 10,000 people.
The approval comes at a big win for the biotech as the product was designated as an orphan drug back in 2015, and until now there have been no authorised biotechnological medicines for this indication.
Eugenio Aringhieri, chief executive officer of Dompé, said: “Neurotrophic Keratitis is a rare disease that is particularly debilitating and until now patients have had no treatment options.
“The approval is a milestone for patients affected by this disease, for the research in this sector, and for our company.”
The European regulator’s decision comes on the back of positive phase II data from two clinical trials concerning 204 patients with the condition. Researchers found that patients treated with cenegermin achieved complete corneal healing after eight weeks compared with patients on placebo.
Aringhieri added: “Oxervate is our first biotech drug and its licensing is due to the hard work of a skilled and passionate team that has believed in this project from the beginning.
“It is a long, complex but exciting journey that has not reached an end but a beginning with this important regulatory step.”
The product will be available as an eye drop solution containing 20 microgram/mL and the company is aiming to “make the product available in other areas outside Europe”.
Professor Harminder Singh Dua, chair and professor of ophthalmology, University of Nottingham and consultant ophthalmologist at the Nottingham University Hospital, said: “The cause of neurotrophic keratitis is linked to damage to the trigeminal nerve, which can lead to the loss of corneal sensitivity and in the most severe cases, it can lead to ulcers, aseptic necrosis and corneal perforation, resulting in impaired vision of those affected.
“Considering the severity of the disease and the lack of viable alternatives, having a therapeutic option that can act on corneal lesions is an important development for the community of ophthalmologists and to the patients themselves.”