By Kristen Mulvihill
Scheie Vision Summer 2019
In December 2018, the first patient in the United States was treated at the Scheie Eye Institute with Oxervate eye drops, a breakthrough therapy to treat neurotrophic keratitis.
Oxervate is the first application of a human nerve growth factor as a drug or treatment to be approved by the U.S. Food and Drug Administration (FDA). Approved in August 2018, Oxervate is also the first topical biologic medication (i.e. a drug produced using a living system) approved in the field of ophthalmology.
Neurotrophic keratitis (NK), also known as neurotrophic keratopathy, is a rare and progressive eye disease affecting the cornea, which can lead to corneal scarring and vision loss. NK is primarily caused by damage to the trigeminal nerve – the largest of the cranial nerves – which conveys sensory information. This damage can lead to loss of corneal sensitivity, ultimately impairing corneal health.
Before Oxervate, existing treatment options for NK were limited to invasive surgical procedures and symptomatic treatments. These treatments, including artificial tears and antibiotics, failed to target the underlying pathology of the disease.
Oxervate eye drops contain cenegermin-bkbj, a recombinant form of human nerve growth factor that is structurally identical to the nerve growth factor (NGF) protein made in ocular tissues. NGF acts directly on corneal epithelial cells, which make up the outermost layer of the cornea, to stimulate cell growth and survival. Additionally, NGF is known to bind receptors on lacrimal glands to promote tear production, helping to lubricate and protect the eye.
The safety and efficacy of Oxervate was tested in 151 patients with NK in two clinical trials. Seventy percent of patients treated with the eye drops demonstrated complete corneal healing in eight weeks.
Mina Massaro-Giordano, MD, was the Principal Investigator for the study at the Scheie Eye Institute. Scheie was instrumental in enrolling the most patients in the U.S. to demonstrate Oxervate’s efficacy in treating NK. This achievement was essential for the FDA approval of Oxervate.
“To lead a trial that ultimately leads to an approved treatment is really exciting and gratifying,” said Dr. Massaro.
Dr. Massaro was also the first physician in the U.S. to treat NK patients with this new therapy.
Oxervate is the first therapy from Dompé, a leading biopharmaceutical company in Italy, that is available in the United States. Dompé focuses on the development and accessibility of innovative therapeutic solutions for health issues that affect patients worldwide.