Oxervate Lawsuits and Settlement Lawyers

If you or a loved one experienced serious side effects or injuries after using Oxervate (cenegermin) for neurotrophic keratitis, you may be entitled to compensation. Our attorneys are investigating Oxervate lawsuits to help victims recover damages for medical expenses, pain, and other losses. 

If you or a loved one has been impacted by Oxervate, our law firm can help you understand your right to pursue legal action for justice. Call (800) 277-1193 or complete a short Free Evaluation Form

Oxevate lawsuit

What Is Oxervate?  

Oxervate is an eye drop approved by the U.S. Food and Drug Administration in 2018 to treat neurotrophic keratitis, a rare condition that damages the cornea and can cause vision loss. The drug works by stimulating the growth of nerve cells in the cornea to promote healing. Although it was marketed as a promising treatment for corneal injuries, reports suggest it may carry serious risks for some patients.  

Why Are People Filing Oxervate Lawsuits?  

As of June 30, 2024, a total of 6,619 adverse events have been reported to the FDA Adverse Event Reporting System (FAERS), where cenegermin was listed as a primary or secondary suspect drug. Of these

  • 994 cases (15.02%) were classified as serious
  • 154 cases (2.33%) resulted in death

Lawsuits claim that Dompé, the manufacturer of Oxervate, failed to warn patients and healthcare providers adequately about the drug’s risks. Some patients allege that they would have chosen different treatments if they had been properly informed.

Complaints also highlight the financial and emotional toll of managing Oxervate’s side effects, which sometimes led to long-term health issues.  

Why Choose Our Law Firm for Your Oxervate Lawsuit?  

Our law firm has a proven track record of securing significant results in pharmaceutical lawsuits. With decades of experience holding drug manufacturers accountable, we know how to fight for the compensation our clients deserve. We have helped obtain over $80 billion in verdicts and settlements, making us one of the most trusted names in the industry.

When you choose us, you’ll have a dedicated legal team guiding you through every step of the process. Our goal is to get you the justice and financial recovery you need.  

How Much Can You Get in an Oxervate Settlement?  

The amount of compensation depends on your specific circumstances, but you may be able to recover:  

  • Medical expenses (past and future)  
  • Lost wages or reduced earning potential  
  • Pain and suffering  
  • Compensation for vision loss or permanent disability  
  • Punitive damages in cases of severe negligence  

Our attorneys will review your case for free to determine how much you may be entitled to.  

Oxervate’s Hidden Risks: What the Label Doesn’t Tell You  

Despite earning FDA approval as an orphan drug for neurotrophic keratitis, Oxervate’s approval came with a red flag: limited safety data. Only 75 patients were involved in the clinical trials, and early signs of trouble emerged when three participants developed corneal deposits—a complication that didn’t appear in the placebo group. Instead of investigating these risks further, it seems Dompé prioritized bringing the drug to market over patient safety.  

Even after reports of corneal plaques surfaced from real-world use, Oxervate’s official Prescribing Information contains no warnings for patients or doctors. This lack of transparency leaves many unaware of the potential risks tied to the drug.

Overlooked Side Effects: What Studies Reveal About Oxervate  

An analysis published in Expert Opinion on Drug Safety reviewed 3,288 reported side effects linked to Oxervate between 2018 and 2022. Among these, 50 adverse ocular events were uncovered—none of which were mentioned in the drug’s safety label. These included:  

  • Corneal perforation
  • Corneal deposits
  • Eye infections  
  • Inflammation 

The study emphasized that while some side effects were mild, others were severe, with users experiencing painful epithelial plaques and irreversible corneal deposits. The researchers warned:  

“The safety information on the label is incomplete… and the occurrence of painful epithelial plaques and irreversible corneal deposits after cenegermin usage have been reported.”  

Can Oxervate Lead to Vision Loss?  

The FDA has logged more than 591 reports of visual impairments linked to Oxervate. These range from blurred vision to complete blindness, often resulting from corneal ulcers and deposits. The severity of vision loss depends on the size and placement of these abnormalities on the cornea.  

corneal ulcer oxervate lawsuit

Corneal Ulcers: A Serious Risk Linked to Oxervate

The exact cause of corneal ulcers from Oxevate remains under investigation. However, scientists believe allergic reactions to cenegermin can trigger inflammation that weakens the cornea’s protective barrier, making it vulnerable to ulcers.  

Corneal ulcers impact vision in several ways:

  • Infections and Inflammation: Ulcers trigger swelling, clouding the cornea and reducing transparency, which blurs vision.
  • Scarring: Healed ulcers may leave scars that interfere with light entering the eye, distorting vision.  
  • Perforation: Severe ulcers can penetrate the cornea, leading to vision loss and possibly causing serious internal infections.

Signs of a Corneal Ulcer  

  • Intense Pain: Ulcers cause sharp pain due to the cornea’s high sensitivity.  
  • Eye Redness: Surrounding tissue becomes inflamed and irritated.  
  • Blurry Vision: Ulcers disrupt the cornea’s clarity, making it hard to see clearly.  
  • Light Sensitivity: The eye becomes highly sensitive to light, known as photophobia.  
  • Watery Discharge: Irritation triggers excess tearing.  
  • Pus or Fluid Buildup: Infected ulcers often produce thick yellow or green discharge.  
  • Visible Marks: Some ulcers appear as white or gray spots on the cornea.  

Corneal Deposits: Another Oxervate Side Effect

Cenegermin, the active ingredient in Oxervate, helps repair nerve damage, but under certain conditions, it can crystallize. These crystallizations form corneal deposits—protein clusters that can cause discomfort and disrupt vision. Complications from corneal deposits include:

  • Light Distortion: Protein deposits scatter light, resulting in blurred vision, glare, and difficulty focusing.  
  • Ongoing Irritation: Chronic irritation from deposits can worsen corneal damage over time, triggering more deposits or inflammation that compromises vision.  

Symptoms of Corneal Deposits  

  • Blurred Vision: Deposits scatter light, creating a cloudy or distorted visual field.  
  • Visible Spots: Patients may notice white or grayish spots on the cornea.  
  • Irritation: Deposits can feel like a foreign object stuck in the eye, causing persistent discomfort.
artificial cornea implant

Corneal Transplants: When Oxervate Causes Lasting Damage  

In some cases, Oxervate causes damage so severe that corneal transplant surgery becomes necessary. The FDA has reported at least 45 instances where users required transplants due to ulcers or deposits that compromised their vision. Examples include:  

Keratoplasty  

  • Procedure: Damaged corneal tissue is replaced with donor tissue.  
  • When Used: This surgery is recommended when scarring from ulcers or severe deposits makes it impossible to restore clear vision through other treatments.  

Keratoprosthesis

  • Procedure: An artificial cornea is implanted when donor transplants are not feasible.  
  • When Used: This procedure is reserved for patients with multiple failed corneal transplants or severe structural damage from repeated ulcers or infections.  

If you or a family member has been affected by Oxervate, our law firm is here to help you explore your legal options for seeking justice. Call us at (800) 277-1193 or fill out our Free Evaluation Form today.

New Research Points to Ongoing Safety Issues with Oxervate  

Medical reports and FDA data continue to expose serious complications from Oxervate use—complications not listed on the drug’s safety label.  

  • Calcium Deposits: A 2022 report in Cornea documented five cases where patients developed rapid corneal opacity after starting Oxervate. Even after stopping the treatment, these deposits persisted, with some patients requiring corneal transplants.  
  • Contact Lens Issues: A patient described in the American Journal of Ophthalmology experienced repeated deposits forming during an eight-week Oxervate treatment, despite using bandage contact lenses.  
  • Unexpected Plaques: A 2023 case study detailed a 72-year-old patient who developed a thick, white plaque on his cornea just 22 days into Oxervate therapy. The plaque required surgical removal, even though his initial symptoms had improved.  

These cases underscore the need for better safety warnings and more thorough research into the long-term risks of Oxervate.

Scientific Studies About Oxervate Side Effects 

The following list summarizes key scientific studies about Oxervate (cenegermin) and its reported side effects. These studies focus on corneal deposits, which are calcium or drug-related buildups in the cornea.  

Li et al. (2024)  

  • Study Type: Disproportionality analysis  
  • Findings: A review of data from the FDA Adverse Event Reporting System (FAERS) identified 32 cases of corneal deposits linked to cenegermin treatment.  
  • Key Result: Greater-than-expected reporting of corneal deposits was found with Oxervate when compared to all other drugs, as evidenced by a reporting odds ratio (ROR) of 418.67. 

Morcos et al. (2024) 

  • Study Type: Case series
  • Findings: Five patients developed calcific band keratopathy, a type of corneal calcium buildup, within one month of finishing an 8-week Oxervate course.  
  • Outcome: The deposits persisted after stopping the drug. Two patients improved after superficial keratectomy (surgery to remove deposits), but one experienced a recurrence.  

Surico et al. (2023)  

  • Study Type: Case report  
  • Findings: A corneal plaque developed 22 days after starting Oxervate.  
  • Outcome: The plaque was successfully removed without further complications.  

Qureshi et al. (2022)  

  • Study Type: Case series  
  • Findings: Five patients developed calcium deposits within 1 to 4 weeks of starting Oxervate. These deposits caused varying levels of vision problems.  
  • Outcome: Four patients experienced incomplete or no resolution after stopping the drug. Treatments included keratectomy, debridement, and one patient received an artificial cornea.  

White & Affeldt (2022) 

  • Study Type: Case report  
  • Findings: A patient developed extensive drug-related deposits over an 8-week treatment period.  
  • Outcome: The deposits were asymptomatic and cleared on their own but reappeared when bandage contact lenses were reapplied.  

Pflugfelder et al. (2020) 

  • Study Type: Clinical trial  
  • Findings: Corneal deposits were found in 1 of 23 patients (4.3%) receiving Oxervate, compared to none in the control group.  

Weinlander et al. (2020)

  • Study Type: Case report  
  • Findings: A plaque developed 6.5 weeks into Oxervate treatment, leading to decreased vision and pain.  
  • Outcome: The lesion resolved, and vision improved after stopping the medication.

These studies reveal that corneal deposits and other complications may occur during or after Oxervate use, leading to vision problems or the need for medical interventions.

Our Drug Injury Lawyers Are Investigating Oxervate Cases  

Have you or a loved one experienced issues with Oxervate? Our legal team can assist you in understanding your rights and pursuing justice.

Contact us at (800) 277-1193 or complete a Free Evaluation Form to get started.