EU CHMP recommends approval of Oxervate (cenegermin) in moderate to severe neurotrophic keratitis- Dompé
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Oxervate (cenegermin), from Dompé, intended for the treatment of moderate to severe neurotrophic keratitis. Oxervate, which was designated as an orphan medicinal product on 14 December 2015, was reviewed under EMA’s accelerated assessment programme. Oxervate will be available as a 20 microgram/ml eye drops solution.
The benefits with Oxervate are its ability to stimulate corneal healing and restore ocular surface integrity in patients with neurotrophic keratitis suffering from persistent epithelial defects or corneal ulcers. The most common side effects are eye pain, eye inflammation, increased lacrimation and foreign body sensation in the eye.