EMA recommends grant for Oxervate to treat neurotrophic keratitis

The EMA (European Medicines Agency) has recommended grant for marketing authorisation in the European Union (EU) for Oxervate (cenegermin) to treat neurotrophic keratitis. Oxervate is a copy of a human growth factor called nerve growth factor. When given as eye drops to patients with neurotrophic keratitis, it is expected to help restore some of the normal healing processes in the eye and repair the damage to the cornea.

Oxervate is produced by ‘recombinant DNA technology’. It is made by bacteria into which a gene (DNA) has been introduced, that enables the bacteria to produce human nerve growth factor. The two phase II clinical trials in 204 patients with moderate and severe neurotrophic keratitis. Both studies showed that after eight weeks, more patients treated with Oxervate achieved complete corneal healing than those treated with placebo.

The most common adverse reactions observed with Oxervate included eye pain, eye inflammation, increased lacrimation (secretion of tears), eyelid pain and a foreign-body sensation in the eye.

Neurotrophic keratitis only affects a small number of patients, and to encourage development of a treatment, Oxervate received an orphan designation from EMA’s Committee for Orphan Medicinal Products (COMP) in 2015.

The opinion adopted by the CHMP at its May 2017 meeting is an intermediary step on Oxervate’s path to patient access. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.