According to a story from BioSpace, the US Food and Drug Administration (FDA) recently approved the drug Oxervate (cenegermin). This treatment is the first FDA approved therapy for the rare disease of the cornea known as neurotrophic keratitis. With this approval, patients that are dealing with this rare illness will have an FDA certified treatment for their disease for the very first time.
About Neurotrophic Keratitis
Neurotrophic keratitis is a degenerative disease that affects the cornea and is the result of damage to the trigeminal nerve. There are several potential causes of damage to this nerve, including other conditions, neurosurgery, viral infections, corneal surgery, physical damage, chemical burns, and chronic, long term use of contact lenses and/or topical medications. Aneurysms and tumors in the area could also cause damage. Systemic diseases such as leprosy, multiple sclerosis, and diabetes are also potential causes. The disease results in changes to the cornea that affect vision, such as changes in sensitivity, melting, perforation, ulceration, breakdown of the corneal epithelium, and poor corneal healing. Diagnosing neurotrophic keratitis can be difficult and often relies on knowledge of the patient’s medical history and close eye examination. Treatment options are limited and focus on halting the progression of damage to the cornea. To learn more about neurotrophic keratitis, click here.
About Oxervate
Oxervate is a significant step forward for the treatment of neurotrophic keratitis. In severe disease, surgery was often necessary to maintain function, but even these procedures cannot prevent the disease from progressing. Oxervate can actually allow the patient’s corneal to heal on its own. Oxervate is a recombinant form of human nerve growth factor.
The approval of the new treatment comes after impressive data from clinical trials. In the trial, Oxervate was able to completely heal the cornea in 70 percent of patients that were treated with it over a period of eight weeks. The trial involved a total of 151 patients. The study also found that the drug was relatively safe. Side effects of treatment can include eye inflammation, eye pain, watery eyes, and enlargement of the blood vessels in the eye.
Overall, it seems like neurotrophic keratitis patients should be very excited about this new approval.
