Oxervate Effective at Managing Hard-to-treat NK, Case Study Reports

Oxervate Effective at Managing Hard-to-treat NK, Case Study Reports

Adding Oxervate (cenegermin) eye drops to conventional treatment approaches may successfully manage hard-to-treat neurotrophic keratitis (NK) associated with eye surgery and persistent infections, a case study suggests.

This case adds to the increasing number of reports providing real-world evidence of Oxervate’s effectiveness in the treatment of NK, supporting its use in this patient population.

The case study, “A Novel Treatment for Neurotrophic Corneal Ulcer Using Topical Cenegermin (OXERVATE) Containing Recombinant Human Nerve Growth Factor,” was published in the Cureus Journal of Medical Science.

Neurotrophic keratitis is a degenerative disease that affects the cornea, the eye’s transparent and protective outer layer. The disease is caused by damage to the nerves serving the cornea, which leads to a loss of sensation and the breakdown of its epithelium, or outer layer.

These lesions can evolve into a corneal ulcer, which can manifest as a thinning of the cornea and leave the eye more susceptible to infection. In more advanced stages, patients may develop a hole or opening to the inside of the eye, which eventually may lead to vision loss.

Developed by Dompé, Oxervate has been the only approved therapy for NK since 2018 in the U.S. and 2019 in Europe. It is commonly prescribed to treat NK cases caused by viral infections, eye injury, overuse of medications and contact lenses, and some surgical procedures.

Oxervate’s active ingredient is a lab-made human nerve growth factor (NGF) that mimics the naturally occurring NGF in the eye. NGF helps to maintain and heal nerves of the cornea and promotes corneal healing and tear production — all of which are affected in NK.

Its approval was mainly based on data from two Phase 2 clinical trials, which showed that eight weeks of treatment with Oxervate was superior to sham eye drops at halting disease progression and improving corneal healing.

However, clinical experience with the therapy is still limited and there is no published evidence comparing its effectiveness with other treatments commonly used to manage NK.

Researchers in the U.S. have now reported the case of an 84-year-old woman whose NK was successfully managed only when Oxervate was added to conventional treatment.

The patient had a history of diabetes and chronic dry eye disease. Together, along with a previous eye surgery and persistent infection and inflammation in her left cornea, these had contributed to the development of severe NK.

Given that multiple non-surgical interventions failed to prevent further corneal damage, the woman underwent surgery to replace her left cornea with donor tissue (corneal transplant). However, the procedure proved ineffective, as two days later, the transplanted cornea already showed a breakdown of its epithelium, or outer layer.

A second corneal transplant was performed, this time in combination with lateral tarsorrhaphy — a partial surgical closure of the lateral part of the upper and lower eyelids to protect the cornea from exposure and improve its healing. Nine days later, epithelial damage was present at 40% of the surface of the transplanted cornea.

Over the following month, multiple interventions continued to be applied or were initiated for the first time, without signs of NK resolution and with further deterioration of the patient’s vision. These included antibiotics, steroids, lubricants, amniotic membrane transplant, autologous (own) serum eye drops, and bandage contact lens, which were used to protect the cornea from the natural friction of blinking eyelids.

At that point, Oxervate eye drops, given six times a day, were added to the woman’s treatment regimen. Her vision and corneal health began to improve within five weeks and, after eight weeks of continuous treatment, her corneal ulcer had totally resolved.

Oxervate dosing was reduced to four times a day, while most of the other therapeutic approaches were maintained. The woman’s quality of life and vision both have since improved, the researchers noted.

“We describe the effective utilization of recombinant human nerve growth factor in the management of NK associated with [corneal transplant],” the researchers wrote, adding that “further studies are warranted to establish the efficacy of [Oxervate] added to conventional treatments for NK in the complicated corneal [transplant] patient.”

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