Oxervate is an eye drop that treats a rare eye disease called Neurotrophic Keratitis (NK), but some patients are developing corneal deposits and white plaques on their eyes.
Need a Texas Oxervate Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you had eye injuries from Oxervate, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
What is the Problem?
Oxervate was originally welcomed as a first-ever treatment for a rare eye disease called Neurotrophic Keratitis (NK), but doctors are now concerned about reports of an unusual side effect in which patients develop white plaques on the outer surface of their eyes.
Corneal Deposits & White Plaques Linked to Oxervate
Oxervate has been linked to corneal deposits, corneal plaques, and vision loss, which may require surgery. These side effects are not listed on the warning label for Oxervate. These white plaques develop rapidly (within a couple weeks of starting treatment with Oxervate) and they do not go away when the patient stops using Oxervate.
Early Signs of Eye Problems in Oxervate Study
The FDA approved Oxervate based on a small safety study involving 75 patients because it was designated as an “orphan drug” for a very rare disease. During this study, 3 patients on Oxervate developed corneal deposits, vs. 0 patients on a placebo.
What is Oxervate?
Oxervate (cenegermin) is a prescription eye drop medication that is used to treat a rare eye disease called Neurotrophic Keratitis (NK). It was created by the Italian pharmaceutical company Dompẻ.
Oxervate: Orphan Drug Fast-Tracked Through FDA Approval
It was once an “orphan drug,” but the FDA fast-tracked Oxervate through the approval process in August 2018, making it a first-of-its-kind treatment for NK. The active ingredient, cenegermin, is a recombinant human nerve growth factor (rhNGF) that works by stimulating the recovery of sensory neurons.
What is Neurotrophic Keratitis?
People with Neurotrophic Keratitis (NK) suffer from progressive nerve damage that reduces sensation to their eyes. They may not feel when they need to blink, which causes long-term problems with dryness and damage to the cornea (the clear outer layer covering the eyes). They may develop corneal epithelial defects, ulcers, and corneal perforation, which can result in vision loss.
What is the Risk?
Some of the most serious side effects linked to Oxervate include:
- Vision loss
- Blindness
- Plaques on the eye
- Corneal deposits
- Corneal plaques
- Ulcers (sores that do not heal)
- Needing a corneal transplant
- Scarring
- Severe eye pain and swelling
- Sensitivity to light
- And more
Case Report of Corneal Plaques Linked to Oxervate
In March 2024, a report by researchers at Harvard Medical School described patients on Oxervate who developed an unusual, painful, white, thick plaque on the surface of their eyes.
The report describes “painful epithelial plaques and irreversible corneal deposits.” The researchers warned:
“The safety information on the label is incomplete … Real-world data on long-term ocular safety are lacking. [We recommend] close monitoring to early identify and manage adverse reactions that may cause occurrence of serious irreversible consequences.”
Another Case Report of Oxervate Eye Plaques
In January 2022, another report looked at 5 patients who developed corneal deposits after being treated with Oxervate.
The authors described the eye injury as “a white opacity in varying layers of the cornea, consistent with calcium deposition, during treatment with Oxervate.”
Alarmingly, the white plaques were “visually significant” and “developed rapidly over the course of a few weeks.” Furthermore, they did not go away when the patient stopped taking Oxervate.
The corneal deposits “may be irreversible and may require keratoplasty for visual rehabilitation,” according to the warning.
72-Year-Old Man Develops Oxervate Eye Plaques
In November 2023, a report described a 72-year-old man who developed corneal eye plaques while using Oxervate within 22 days of starting treatment. “An unusual white, thick, adherent corneal superficial plaque formed,” according to the report. He stopped taking Oxervate and doctors were able to remove the plaque.
Need an Oxervate Lawyer in Texas?
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