First biotech neurotrophic keratitis drug Oxervate approved in Europe

Privately-held Italian biopharma company Dompé today revealed that the European Commission has granted a marketing authorization for Oxervate (cenegermin eye drops) for the treatment of moderate to severe neurotrophic keratitis.

This is the first biotechnology treatment authorized for neurotrophic keratitis in adults in Europe. The product responds to the needs of patients affected by this rare and severely debilitating eye disease that can cause vision loss. The approval comes following a positive recommendation in May from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

In 2015, the product was designated as an orphan drug in Europe for the treatment of neurotrophic keratitis, a rare eye disease that affects less than five out of every 10,000 people. Until now, there have been no authorized drugs for this condition.