The European Commission has granted marketing authorisation for cenegermin eye drops (Oxervate, Dompé) for the treatment of moderate to severe neurotrophic keratitis.
It is the first drug authorised by the European Commission for adults in Europe with neurotrophic keratitis, a severely debilitating eye disease which affects fewer than 5 out of 10,000 people.
“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,” said Harminder Singh Dua, chair and professor of ophthalmology, University of Nottingham.
Cenegermin received orphan drug designation for neurotrophic keratitis in 2015.
In this condition, damage to the trigeminal nerve or its branches causes loss of sensation in the cornea. In the most severe cases, it can lead to ulcers, aseptic necrosis and corneal perforation, resulting in impaired vision of those affected.
The initial damage can result from herpes simplex and herpes zoster viral infections, trigeminal neuralgia surgery, acoustic neuroma, and toxicity from chronic use of topical ocular medications.
The sensory neurons in the cornea directly influence the integrity of the corneal epithelium; without them epithelial cells swell, lose microvilli, and produce abnormal basal lamina. This can slow mitosis, leading to epithelial breakdown.
This makes the cornea prone to injury that can lead to corneal ulcers, perforation, infection, and scarring.
Discontinuation of medications that caused the syndrome may allow healing, but until now, no medication could restore decreased corneal sensitivity or induce corneal healing.
Cenegermin is the recombinant version of the human nerve growth factor (NGF) discovered by Nobel Laureate Rita Levi Montalcini. This protein is naturally produced by the human body and is involved in the development, maintenance, and survival of nerve cells.
Dompé produces cenegermin through recombinant DNA technology, with the introduction of a gene (DNA) into bacteria, causing them to produce the human nerve growth factor.