Oxervate, an eye drop used to treat neurotrophic keratitis (NK), has been linked to the development of eye plaques, corneal deposits, and vision loss.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Oxervate induced injury cases in all 50 states. If you or somebody you know was diagnosed with plaques on the eye, corneal deposits, or blindness after using Oxervate, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Oxervate Label Fails To Warn About Plaques on the Eye
Because Oxervate was an orphan drug for a very rare disease, the FDA granted it rapid approval based on a small safety study. The new drug application included only 75 patients.
In the study, 3 patients on Oxervate developed corneal deposits, vs. zero patients on a placebo. Even so, the Prescribing Information did not include warnings about corneal deposits, plaques on the eyes, or other severe side effects.
Severe Eye Side Effects of Oxervate
- 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
Oxervate Patients May Develop Unusual Eye Plaques
There are reports of Oxervate patients who developed a painful, white, thick plaque on the surface of their eyes, according to a report by researchers at The Department of Ophthalmology, Massachusetts Eye and Ear Institute, Harvard Medical School.
These patients developed “painful epithelial plaques and irreversible corneal deposits” after using Oxervate, according to FDA reports.
The researchers warned: “The safety information on the label is incomplete … Real-world data on long-term ocular safety are lacking.” They recommended “close monitoring to early identify and manage adverse reactions that may cause occurrence of serious irreversible consequences.”
Case Report: 5 Patients With Oxervate Eye Plaques
In January 2022, another report identified 5 patients who developed “a white opacity in varying layers of the cornea, consistent with calcium deposition, during treatment with Oxervate.”
The authors of the study described the injury as an acute calcific band keratopathy.
The report was alarming because the “opacity developed rapidly over the course of a few weeks.” These corneal deposits were “visually significant” and did not go away when the patient stopped taking Oxervate. The experts warned that “the opacity may be irreversible and may require keratoplasty for visual rehabilitation.”
Case Report: 72-Year-Old Man With Eye Plaque From Oxervate
In November 2023, researchers published a case report of a 72-year-old man who was successfully treated with Oxervate. However, just 22 days after starting treatment, “an unusual white, thick, adherent corneal superficial plaque formed.” Treatment with Oxervate was stopped and the plaque was carefully removed.
What is Oxervate?
Oxervate is an eye drop medication that is the first-ever treatment for Neurotrophic Keratitis (NK), a rare eye disease that damages the cornea, which is the clear layer covering the colored part of the eyes.
Oxervate was approved by the FDA in August 2018 through a fast-track process for orphan drugs that can treat diseases without a cure. It contains cenegermin, a recombinant human nerve growth factor (rhNGF) that helps nerves heal.
Oxervate is manufactured by Dompẻ, an Italian company that is headquartered in Boston, Massachusetts.
What is Neurotrophic Keratitis?
Neurotropic Keratitis (NK) is a rare degenerative eye disease that occurs when nerve damage causes a loss of sensation to the cornea, which is the clear layer in front of the eye.
People with NK may not be able to feel their eyes due to nerve damage, so they forget to blink or sense that their eyes are too dry. Over time, the dryness causes progressive damage to the cornea.
NK is rare, but it can cause severe complications like cornea ulcers (sores on the eyes that do not heal), vision loss, and blindness.
NK may also occur as a side effect of very common diseases that damage the nerves, such as herpes simplex, shingles, or trigeminal neuralgia. The long-term complications of NK include corneal thinning, ulcers, scarring, perforation of the cornea, vision loss, and blindness.
Prognosis & Treatment Options
Before the approval of Oxervate, the only treatment for NK was palliative, and often involved the use of eye drops, or even surgical intervention to restore sensation by transplanting healthy sensory nerves from other parts of the face into the damaged corneal nerve.
Other Treatments for Corneal Deposits
Other treatments for corneal deposits and plaques on the eyes may include:
- Sewing the eyelid shut temporarily
- In-office therapy with a chelating agent to scrape the plaque off the eye
- Keratoplasty (cornea replacement)
- Corneal grafting
- Keratoprosthesis (surgical procedure where a diseased cornea is replaced with an artificial cornea)
What is the Risk?
The most common side effects of Oxervate include eye pain and inflammation, watery eyes, eyelid pain, and a sensation of a foreign body in the eye. The Prescribing Information does not include warnings about corneal ulcers, plaques on the eyes, or blindness.
Do I Have an Oxervate Lawsuit?
The Schmidt Firm, PLLC is currently accepting Oxervate induced injury cases in all 50 states. If you or somebody you know was diagnosed with plaques on the eye, corneal deposits, or blindness after using Oxervate, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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