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Oxervate Lawsuit: Get the Right Attorney

The eye drops solution Oxervate (cenegermin-bkbj), which is used to treat an eye condition called neurotrophic keratitis (NK), has recently been linked to an increased risk for the development of plaques on the eye, which can lead to corneal ulcers and potential blindness.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

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What is Oxervate?

According to the European Medicine Agency, oxervate is a topical recombinant human nerve growth factor (rhNGF) medicine used to treat neurotrophic keratitis, an eye condition in which damage to the trigeminal nerve supplying the surface of the eye causes loss of sensation and defects that do not heal naturally [1].

Because the number of patients with NK is low, the disease is considered ‘rare’, and Oxervate was designated an ‘orphan medicine’ (a medicine used in rare diseases) in Dec. 2015. Oxervate is manufactured and marketed by Dompé U.S. Inc.

A case report published in the medical journal Cornea in January 2022 [2] looked at incidences of corneal deposits occurring in patients treated with Oxervate for neurotrophic keratopathy.

For the study, the researchers identified 5 patients from 3 institutions who were discovered to have developed a white opacity in different layers of the cornea, indicating calcium deposition, while undergoing treatment with Oxervate. The opacity appeared rapidly, evolving over a few weeks following treatment initiation.

Treatment outcomes varied: one patient underwent a successful superficial keratectomy with ethylenediaminetetraacetic acid chelation, another patient required penetrating keratoplasty, and a third patient received a Boston keratoprosthesis.

We report the rapid onset of a corneal opacity after initiation of treatment with cenegermin in patients with stage 2 or 3 NK, consistent with acute calcific band keratopathy, the authors concluded.  We recommend close monitoring of patients receiving cenegermin therapy because the opacity may be irreversible and may require keratoplasty for visual rehabilitation.

Another study published in Cornea in November 2023 [3] looked at a report of corneal superficial plaque formation after topical recombinant human nerve growth factor treatment for a non-healing epithelial defect in a 72-year-old patient with advanced mucous membrane pemphigoid, limbal stem cell deficiency, and neurotrophic keratopathy.

The patient presented with a recurrent persistent epithelial defect in the right eye. After a long course of unsuccessful epithelial healing, he was administered topical Oxervate (centerman 0.002%), which successfully resolved the epithelial defect. However, on day 22 post-treatment, an unusual white, thick, adherent corneal superficial plaque formed.

Oxervate was discontinued and the plaque was carefully removed. Subsequently, there was no recurrence, and the patient’s epithelial healing remained stable.

Although the successful resolution of the persistent epithelial defect with rhNGF administration was notable, the development of the unusual epithelial overgrowth emphasizes the importance of vigilant monitoring and evaluation when using rhNGF in complex ocular conditions, the researchers concluded. Making informed decisions on the timing of discontinuing rhNGF can lead to desirable effects of the drug while mitigating additional side effects when managing such challenging cases.

On August 28, 2023, a study published in Expert Opinion on Drug Safety [4] attempted to assess the Oxervate-associated eye safety profile in the FDA pharmacovigilance database.

The researchers identified 3288 cases of Oxervate-related ocular adverse events and 56 positive ocular-related signals. Fifty unexpected signals of ocular adverse events were also identified. Eye ulcer was classified as a designated medical event. Twenty adverse events, including corneal perforation, eye infection, corneal deposits, and eye inflammation, were recognized as important medical events.

The safety information on the label is incomplete, and the adverse reactions noted are mostly mild and tolerable, the researchers said. However, the occurrence of painful epithelial plagues and irreversible corneal deposits after cenegermin usage have been reported.

A September 2022 study published in the American Journal of Ophthalmology Case Reports [5] reported for the first time an incidence of drug precipitate deposit formation on both the ocular surface and bandage contact lens (BCL) in a patient treated with topical Oxervate.

The patient was suffering from stage III neurotrophic keratitis and subsequently developed extensive ocular surface and contact lens deposits over the 8-week course of her topical Oxervate therapy. The ocular surface deposits were weakly adherent, detaching and clearing from the cornea within minutes of contact lens removal. They reappeared rapidly and repeatedly however after each of 5 contact lens exchanges.

Topical cenegermin can produce extensive drug precipitate deposits on both the ocular surface and contact lens when used in conjunction with a bandage contact lens, the study’s authors concluded.

Oxervate Side Effects

Serious side effects of Oxervate may include:

  • Eye plaques
  • Eye ulcers
  • Eye infections
  • Corneal ulcers
  • Corneal deposits
  • Corneal perforation
  • Acute Calcific Band Keratopathy
  • Drug Precipitate Deposit Formation
  • Blindness

Other Oxervate Side Effects

Other, less severe side effects of Oxervate eye drops may include [6]:

  • Mild to moderate eye discomfort
  • Eye pain
  • Blurred vision
  • Corneal deposits
  • Feeling of having something in the eye
  • Enlarged blood vessels in the white of the eyes
  • Swelling of the eye
  • Sensitivity to light
  • Increase of tears
  • Headache

Is There an Eye Damage Warning on the Oxervate Label?

No. There are no warnings on the Oxervate labeling about an increased risk for corneal ulcers, plaques, etc.

Instead, Oxervate labels only state that  The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation [7].

What is Neurotrophic Keratitis?

Neurotrophic keratitis is an uncommon eye condition that impacts the cornea, the transparent outer layer of the eye. This layer acts as a window, focusing light entry into the eye.

The cornea bends light, allowing it to pass through the pupil and reach the retina, where specialized cells convert light into nerve impulses. These impulses travel along the optic nerve to the brain, forming images.

Neurotrophic keratitis is caused when the nerves that serve (innervate) the cornea do not function properly; these nerves carry impulses that help the cornea function by eliciting the blink reflex, promote wound healing and increase tear production [8].

Neurotrophic Keratitis Symptoms

Neurotrophic keratitis can lead to mild or even absent symptoms due to reduced corneal sensitivity from damaged nerve endings.

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