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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.
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
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.
The amount of compensation depends on your specific circumstances, but you may be able to recover:
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.
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:
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.”
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.
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:
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:
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:
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.
Medical reports and FDA data continue to expose serious complications from Oxervate use—complications not listed on the drug’s safety label.
These cases underscore the need for better safety warnings and more thorough research into the long-term risks of Oxervate.
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)
Morcos et al. (2024)
Surico et al. (2023)
Qureshi et al. (2022)
White & Affeldt (2022)
Pflugfelder et al. (2020)
Weinlander et al. (2020)
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.
Levin Law