Dompe’s Oxervate is First Treatment Approved in US for Neurotrophic Keratitis

August 24, 2018: By Joan McKenna

Dompe’s Oxervate, a topical eye drop containing cenegermin-bkbj, has received US approval for neurotrophic keratitis (NK), a degenerative disease resulting from a loss of corneal sensation, the FDA announced Aug. 22.

Oxervate is the first US treatment for this indication and is labeled for use in patients age 2 and older.

Dompe, based in Milan, Italy, says Oxervate is the first-ever topical biologic approved in ophthalmology. The European Medicines Agency authorized Oxervate in 2017.

Cenegermin-bkbj is a recombinant human nerve growth factor (rhNGF) structurally identical to the nerve growth factor (NGF) protein made in the human body, including in ocular tissues. The endogenous protein supports corneal integrity though several mechanisms.

Oxervate was studied in 151 patients with neurotrophic keratitis in two eight-week, randomized, controlled, multicenter, double-masked studies. Across both studies, complete corneal healing in eight weeks was demonstrated in 70 percent of patients treated with Oxervate compared with 28 percent of patients treated without it.

The most common adverse reactions in treated eyes were pain, hyperemia, inflammation, and increased lacrimation (watery eyes).

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