Oxervate (cenegermin) is a prescription eye drop developed by Dompe to treat neurotrophic keratitis (NK).
Oxervate received marketing authorization from the European Medicines Agency in 2017 for the treatment of moderate to severe NK. The U.S. Food and Drug Administration approved Oxervate in 2018 with the first U.S. patient receiving the medication in January 2019.
How does Oxervate work?
In NK, the cornea of the eye is not able to sense pressure or stimulation as its outer layer breaks down due to damage to the corneal nerves. In advanced cases, the inner layer of the cornea, called the stroma, can also break down — known as stromal melting — and result in corneal thinning, scarring, and vision loss.
Nerve growth factor (NGF) is a protein that helps to maintain and heal corneal nerves. Cenegermin, the active ingredient in Oxervate, is a recombinant human nerve growth factor (rhNGF) that is structurally identical to the naturally occurring NGF found in the eye.
Similar to natural NGF, cenegermin shows high affinity for the NGF receptor TrkA and low affinity for p75NTR, which are found in the cornea and tear glands. When administered as eye drops, Oxervate acts via the NGF receptors and supports corneal integrity by promoting corneal nerve growth, tear secretion, and proliferation and maintenance of the outer corneal layer or corneal epithelium.
Oxervate in clinical trials
A Phase 1/2 trial (NCT01756456) called REPARO assessed the safety and efficacy of two doses (20 and 10 ug per mL) of rhNGF eye drops in patients with moderate to severe NK. The drops did not contain the antioxidant excipient methionine that would have been added to the final Oxervate product to maintain stability.
The results showed that the topical application of rhNGF improved corneal epithelial integrity in 72% of patients with moderate to severe NK after four to eight weeks of treatment with no adverse events or immune reactions.
A Phase 2 trial (NCT02227147) called NGF0214 then assessed the efficacy of a 20 ug per mL dose of Oxervate with the final formulation containing the methionine antioxidant.
The results showed that the Oxervate formulation was also well-tolerated and promoted safe and steady healing of the cornea over the full eight-week course of the trial.
Other information
The recommended dosing is one drop of Oxervate in the affected eye(s) every two hours, six times a day. This should be continued without fail for eight weeks for the best results.
Eye pain is the most common side effect of Oxervate and was reported in 16% of participants in the clinical trials. Other less common side effects include redness, inflammation, an increase in tear production, and corneal deposits.
Contact lenses must be removed first and reinserted 15 minutes after the application of the drops. Oxervate must be used 15 minutes before using other topical agents on the eyes.
Last updated: Feb. 3, 2020
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