European regulators have agreed to review Italian drugmaker Dompe's orphan drug Oxervate, opening the door to what may potentially become the first biotech treatment available to patients with the more severe forms of an eye condition called neurotrophic keratitis.
Neurotrophic keratitis is a rare degenerative eye disease that affects less than five people in every 10,000, which damages the corneal epithelium and also causes a loss of corneal sensitivity. Corneal ulcers, melting and perforation of the eye can also occur with the more severe forms of the condition, impacting visual capacity.
Various clinical conditions - such as viral infections of the cornea, eye injuries, chemical burns and lesions, corneal surgery, or systemic illnesses such as diabetes - can cause the disease, but as yet there is no direct treatment of the nerve impairment that constitutes its main cause.
Oxervate (cenegermin) is a recombinant form of the human nerve growth factor (NGF), discovered by Nobel Prize winner Rita Levi Montalcini. It is a protein produced naturally by the human body that is responsible for the development, maintenance and survival of nerve cells.
Considering the severity of the condition, the lack of valid treatment options for patients and the innovative nature of the product, the European Medicines Agency will undertake an accelerated assessment of the application, the firm noted.