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Oxervate gets EMA approval for rare degenerative eye disease

The European Medicines Agency (EMA), which evaluates medicinal products for use in Europe, has recommended Oxervate (marketed by Dompé) for marketing authorisation for the treatment of moderate or severe neurotrophic keratitis.

The eye disease results from damage to the trigeminal nerve and subsequent progressive degeneration of the cornea. In severe cases it can lead to blindness.

There are currently no specific pharmacological treatments for the eye disease, which is often managed with artificial tears and antibiotics, as well as surgery, in some cases.

Oxervate, whose active ingredient is cenegermin, is a recombinant form of human nerve growth factor, delivered via eye drops, and is intended to recover an adequate nerve response to preserve and heal the cornea.

The EMA recommendation was based on data from two phase II clinical trials involving 204 patients with moderate and severe disease. In both studies, more Oxervate-treated patients achieved complete corneal healing after eight weeks compared with placebo-treated patients.

The most common adverse reactions included eye and eyelid pain, eye inflammation, increased tear production and a foreign-body sensation in the eye.

Oxervate was reviewed under the EMA’s accelerated assessment programme, intended to increase access to treatments that address unmet medical needs, after receiving orphan designation in 2015. Neurotrophic keratitis is thought to affect between 1 and 5 people out of every 10,000.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202842

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