CHMP Backs Cenegermin (Oxervate) for Neurotrophic Keratitis

Troy Brown, RN

May 19, 2017

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for cenegermin (Oxervate, Dompé farmaceutici S.p.A.) for the treatment of adults with moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis on May 18, 2017.

Cenegermin was designated as an orphan medicinal product on December 14, 2015, and was reviewed under the agency's accelerated assessment program. It will be available as an eye drop solution containing 20 microgram/mL.

Neurotrophic keratitis is a rare eye disease that can result in blindness. "Patients with neurotrophic keratitis have damage to the trigeminal nerve (one of the nerves that supplies the eye). This results in reduced or lack of sensation in the cornea (the clear layer at the front of the eye), and reduced production of the substances that play an important role in repairing damage and ensuring survival of cornea cells," according to an EMA news release.

No satisfactory treatment currently exists for neurotrophic keratitis. On the basis of the extent of their disease, patients may receive eye drops to lubricate the eye, antibiotics to treat eye infections, and protective contact lenses. Some patients may undergo surgery.

Cenegermin is a recombinant form of human nerve growth factor that stimulates corneal epithelial cell growth and survival. It stimulates corneal healing and restores the surface integrity of the eye in patients with persistent epithelial defects or corneal ulcers as a result of neurotrophic keratitis.

"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," according to the EMA news release.

The recommendation follows consideration of data from two phase 2 clinical trials in 204 patients with moderate and severe neurotrophic keratitis. In both studies, more patients treated with cenegermin achieved complete corneal healing after 8 weeks compared with patients treated with placebo.

The most frequent adverse reactions included eye pain, eye inflammation, increased lacrimation, foreign body sensation in the eye, and eyelid pain.

Cenegermin treatment should be initiated and supervised by an ophthalmologist or other healthcare professional experienced in ophthalmology.

Orphan Medicinal Product

EMA's Committee for Orphan Medicinal Products granted cenegermin an orphan designation because neurotrophic keratitis affects only a small number of patients. Such designation provides incentives to encourage development of a treatment, including free scientific advice regarding the clinical and nonclinical aspects of the medicine's dossier.

The CHMP's opinion is an intermediary step to approval. The committee's opinion will go to the European Commission for a decision on whether or not to grant European Union-wide marketing authorization. Once granted, each Member State will make decisions about price and reimbursement after considering "the potential role/use of this medicine in the context of the national health system of that country," EMA explained in the news release.

The Committee for Orphan Medicinal Products will determine whether or not to maintain orphan designation.

The summary of product characteristics will provide detailed recommendations for the use of this product; it will be published in all official European Union languages in the European public assessment report after the European Commission grants marketing authorization.

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