Oxervate lawsuit: Know the Side Effects before You Use

by | Jun 18, 2024 | Product Liability, Medications | 0 comments

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Is your eye treatment safe? In the field of eye care, new treatments promise to restore vision and improve lives.

One such treatment is Oxervate, an eye drop used to treat neurotrophic keratitis, a rare degenerative eye disease.

However, recently, concerns have been raised about serious side effects associated with Oxervate. Reports of severe eye problems, including painful conditions and permanent damage, have caused alarm. Consequently, some patients are suing for compensation for their pain and medical costs.

Let’s explore what neurotrophic keratitis is, why people are filing Oxervate lawsuits, and how to seek compensation.

What is Neurotrophic Keratitis (NK)?

Neurotrophic keratitis is a rare eye disease that affects the cornea, the front part of the eye. It happens when the cornea loses its feeling and can’t sense pain or irritation. This is because the nerves in the cornea are damaged.

Neurotrophic keratitis is a degenerative disease characterized by the loss of corneal sensitivity, leading to corneal ulcers and potentially blindness.


What is Oxervate?

Oxervate is a prescription eye drop developed by an Italian company named Dompé farmaceutici S.p.A. It contains cenegermin, a form of nerve growth factor that mimics a natural protein in the body and helps nerve growth.

Is Oxervate FDA approved? Oxervate is the first treatment for neurotrophic keratitis, approved by the FDA in 2018. When applied to the eye, it helps the damaged nerves in the cornea regenerate, improving sensation and healing.

Oxervate Side Effects

Like all medications, Oxervate also causes side effects. What are the side effects of Oxervate eye drops? 

Here is a list of potential side effects:

  • Blindness
  • Blurred vision
  • Corneal deposits
  • Corneal ulcers
  • Corneal plaques
  • Light sensitivity
  • Corneal perforation
  • Severe eye inflammation

Patients experiencing severe or persistent side effects should contact their healthcare provider immediately.

Key Study: The REPARO Trial

One of the most important studies supporting Oxervate’s approval and its controversy is the REPARO trial. Published in the journal Ophthalmology in 2018, the REPARO trial was a pivotal Phase II study that evaluated the safety and efficacy of cenegermin in patients with neurotrophic keratitis.

The REPARO trial was a randomized, double-masked, vehicle-controlled study involving 156 patients. Participants were randomly assigned to receive either cenegermin eye drops or a placebo vehicle for eight weeks, with follow-up assessments at 4 and 8 weeks after treatment.

The study’s results were promising: 72% of patients treated with cenegermin achieved complete corneal healing at week 8, compared to only 33% in the placebo group. Additionally, the treatment was well-tolerated, with no differences in adverse events between the two groups. The findings were enough to support the FDA’s decision to approve Oxervate for the treatment of neurotrophic keratitis.

However, experts argue that the study had limitations that were not adequately addressed in the marketing materials. For instance, the trial’s short duration and small sample size might not fully capture the long-term safety and efficacy of the drug.

Findings from FDA Data

A study published in Expert Opinion on Drug Safety examined the ocular adverse events associated with cenegermin, a drug used for neurotrophic keratitis, using data from the FDA adverse event reporting system.

Cenegermin is known for having mild side effects, but severe issues like painful epithelial plaques and irreversible corneal deposits have been reported. Analyzing reports from 2018 to 2022, the study identified 3288 cases of ocular adverse events, including 50 unexpected and 20 serious events such as corneal perforation and eye infections. The median time for these events to occur was 6 days.

The findings highlight the need for careful monitoring of patients to detect and manage serious side effects promptly.

Filing an Oxervate Lawsuit

Researchers have found that Oxervate eye drops may lead to serious eye problems not mentioned on the warning label. Although no Oxervate lawsuits have been filed yet, lawyers across the U.S. are investigating claims against Dompé. These lawsuits seek compensation for patients who were not adequately warned about the risks of corneal ulcers and deposits, which they developed due to Oxervate.

While Dompé reported significant corneal healing in clinical trials with Oxervate, evidence now suggests that up to 10% of users developed corneal deposits, potentially leading to serious vision problems. Thousands of users have reported severe vision issues, including blindness, blurred vision, and a sensation of a foreign body in the eye.

Lawyers are examining whether Dompé failed to inform users about these risks. If it is proven that the manufacturer knew about the potential eye disorders and did not disclose them, affected individuals may be entitled to financial compensation. If you’ve had vision issues from using Oxervate, you might be eligible for compensation.

To conclude,

Oxervate eye drops can offer significant benefits, but it is crucial to be fully aware of the risks and side effects before using them. Despite their benefits, some patients have experienced adverse effects, leading to significant health issues.

If you have experienced any injuries or adverse effects from Oxervate, it is important to understand your rights and consider filing an Oxervate lawsuit to seek compensation. Understanding the risks and knowing your legal options can help protect your health and rights.

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