Oxervate eye drops filed at EU by Dompe to treat neurotrophic keratitis.
Domp� announced the acceptance of the registration application submitted to the European Medicines Agency (EMA) for Oxervate eye drops, for the treatment of moderate and severe neurotrophic keratitis in adult patients. Acceptance by EMA constitutes the initiation of the dossier's scientific review procedure, in order to obtain authorisation to market the medicinal product, which was designated an orphan drug for the treatment of neurotrophic keratitis by EMA's committee for Orphan Medicinal Products (COMP) in 2015.
Cenegermin, the product's active substance, is the recombinant version 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 and that is responsible for the development, maintenance and survival of nerve cells.