If you suffer from the eye disease neurotrophic keratitis, your doctor may soon consider prescribing the topical eye drop Oxervate (cenegermin). It is the first drug approved by the US Food and Drug Administration (FDA) as a treatment for the rare condition.
The drug, developed by Italian biopharmaceutical firm Dompé farmaceutici SpA, was granted Priority Review designation and Orphan Drug status by the FDA.
What is neurotrophic keratitis?
Neurotrophic keratitis is a degenerative condition affecting the cornea, the transparent front part of the eye. It is caused by damage to the trigeminal nerve, which helps maintains the cornea and plays an important sensory role. Damage to this nerve can lead to poor healing of the cornea, corneal ulceration, poor corneal sensitivity and other complications.
Nerve damage can have several different causes, including herpetic and other infections, eye or neurological surgeries, physical injury, and certain other systemic conditions that adversely affect sensation.
The condition is classified as a rare disease and is estimated to affect less than five in 10,000 people. However, for those living with the condition, it can have a significant impact on their quality of life, as was noted by Wiley Chambers, MD, an ophthalmologist at the FDA’s Center for Drug Evaluation and Research, who commented: “The impact of this serious condition on an individual patient can be devastating.”
What is Oxervate (cenegermin)?
Oxervate is a prescription topical eye drop containing cenegermin, a copy of a human growth factor called nerve growth factor. When administered to patients with neurotrophic keratitis, it aids restoration of the eye’s normal healing processes, helping repair some of the damage to the cornea associated with neurotrophic keratitis.
The drug is taken over an eight-week period and can be self-administered at home.
What are the side effects of Oxervate?
The most common side effects associated with Oxervate are eye pain, enlargement of blood vessels in the whites of the eye (also called ocular hyperemia), eye inflammation, and watery eyes.
Who is Oxervate indicated for?
Oxervate is a prescription medication approved for use in adults and children over the age of two with neurotrophic keratitis.
How effective is Oxervate?
The efficacy of medication may vary among patients, but the results of the clinical trials involving Oxervate will be encouraging for those suffering from neurotrophic keratitis. The FDA reviewed data from two clinical trials involving a total of 151 patients with neurotrophic keratitis.
These demonstrated that seven out of ten patients treated with cenegermin, the active ingredient in Oxervate, experienced complete healing of the corneas in two months, compared to less than three in ten of the patients treated without cenegermin. Furthermore, 80 percent of patients healed with Oxervate remained healed after one year.
For more information on Oxervate, visit: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761094s000lbl.pdf