Oxervate Lawsuit Investigation

The product liability lawyers at Saiontz & Kirk, P.A. are investigating Oxervate lawsuits against the drug manufacturer Dompé, on behalf of individuals who experienced vision loss, underwent corneal surgery, or suffered undisclosed side effects after using Oxervate eye drops.

Oxervate (cenegermin bkbj) is a human nerve growth factor (NGF) drug that was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) in 2015. It was later approved in 2018 to treat neurotrophic keratitis, which is a degenerative corneal disease characterized by decreased or absent corneal sensation.

Early clinical trials of Oxervate showed that the eye drops could facilitate complete corneal healing compared to a placebo. However, these trials also revealed that up to 10% of participants developed corneal deposits, which are accumulations of material on the cornea that can severely impair vision or even cause total vision loss.

Despite these findings, the manufacturer did not disclose corneal deposits and potential corneal ulcers as a side effect of Oxervate. Since the drug’s release, the FDA has received thousands of reports from users experiencing a range of eye disorders, including blindness, blurred vision, sensitivity to light, and the sensation of a foreign body in the eye.

Our lawyers are investigating claims for individuals who have suffered Oxervate side effects that could have been avoided if adequate warnings had been provided about the importance of monitoring for corneal deposits or vision loss.

Oxervate Warning Label Fails to Disclose Eye Plaque Risks

Oxervate is classified as an orphan drug, since it treats a rare condition. This allowed the drug maker to obtain expedited approval from the FDA, based on limited safety data involving just 75 patients.

During the clinical trials, three participants treated with Oxervate exhibited corneal deposits compared to none in the placebo group. Although these findings provided a clear signal to the drug maker that this may be a side effect of Oxervate, it appears that Dompe placed a desire for profits before consumer safety by failing to further investigate the corneal problems.

Oxervate’s Prescribing Information does not warn patients or doctors about potential corneal deposits or plaques on the eyes. However, these problems have been reported by a large number of users since the medication was introduced.

Unreported Corneal Effects in Oxervate Labeling

Research published in the journal Expert Opinion on Drug Safety analyzed 3,288 incidents of Oxervate side effects reported between 2018 and 2022. Out of these, 50 ocular events were identified that involved problems not mentioned on the drug’s safety label, including

• Corneal perforation
• Corneal deposits
• Eye infection, and
• Eye inflammation

Researchers emphasized that while most adverse reactions were mild and tolerable, severe outcomes like painful epithelial plaques and permanent corneal deposits following cenegermin (the active ingredient in Oxervate) treatment have occurred.

Can Oxervate Cause Vision Loss?

The FDA has documented over 591 cases of visual impairments in users of Oxervate, ranging from blurred vision and reduced visual acuity to complete blindness. These issues typically arise from corneal ulcers and deposits linked to the medication. The impact on vision depends on how large and where these ulcers or deposits are located on the cornea.

Vision Loss Due to Corneal Ulcers:

• Infection and Inflammation: Corneal ulcers usually stem from an infection that triggers inflammation, compromising the cornea’s transparency and resulting in cloudiness that obstructs vision.
• Scarring: Once an ulcer heals, it can leave a scar that, depending on its size and position, may significantly obstruct vision by altering the path of light entering the eye.
• Perforation: In extreme cases, an ulcer may perforate the cornea, creating an opening that can cause severe vision loss and increase the risk of a serious internal eye infection (endophthalmitis), which can further compromise vision and eye structure.

Vision Loss from Corneal Deposits:

• Optical Interference: Deposits, often from crystallized proteins in the medication, can accumulate on or within the cornea, scattering or blocking light and causing blurred vision or glare.
• Chronic Irritation and Damage: Although the immediate effects may be less severe than those of ulcers, deposits can chronically irritate the eye, potentially leading to more severe corneal changes, further deposits, or secondary inflammation that reduces vision clarity.

Research and reports from the FDA suggest that users of Oxervate eye drops face a risk of developing corneal ulcers and deposits, necessitating medical attention to mitigate potential vision loss.

Can Oxervate Cause Corneal Deposits?

Oxervate, which contains the protein cenegermin, functions as a nerve growth factor medication utilizing proteins to facilitate healing. However, under certain conditions, such as changes in the eye’s pH or interactions with other ions and molecules in the tear film, cenegermin can crystallize. These crystallizations are what form the corneal deposits associated with the use of the drug.

These deposits are essentially clusters of protein that settle on the cornea, which can cause visual disturbances and discomfort. They generally appear as small, opaque or translucent spots on the cornea that might affect vision if they are extensive or located in the central visual axis.

Symptoms of Corneal Deposits

Corneal deposits, while generally less severe than ulcers, can still cause discomfort and affect vision. Symptoms include:

• Visual Disturbances: Light scattering caused by deposits can lead to blurred or cloudy vision.
• Visible Spots: These may appear as white or grayish spots on the cornea, noticeable by both eye care professionals and, in some cases, the patient.
• Slight Discomfort: Deposits can create a sensation as though a foreign object is in the eye.

Can Oxervate Cause Corneal Ulcers?

The exact mechanism by which Oxervate might cause corneal ulcers is still under investigation, but it is hypothesized that allergic reactions to cenegermin could trigger severe inflammation and disrupt the corneal surface and epithelium.

This disruption compromises the protective epithelial barrier, making the underlying tissue more prone to infections and potentially leading to ulcers.

Symptoms of Corneal Ulcers

• Severe Pain: The cornea’s dense nerve supply makes any damage, such as an ulcer, particularly painful.
• Redness: The area around the ulcer may become inflamed and irritated.
• Blurred Vision: Ulcers can disturb the cornea’s smoothness and clarity, affecting vision.
• Sensitivity to Light (Photophobia): An inflamed eye may become excessively sensitive to light.
• Watery Eyes: Excessive tear production can occur as a response to irritation or discomfort.
• Pus or Discharge: Infectious ulcers can produce a thick, often yellow or greenish discharge, signaling the presence of pus.
• White or Gray Spot on the Cornea: This mark, indicative of an ulcer, may be visible on the cornea and can sometimes be seen without magnification, depending on its size and depth.

Corneal Transplant Surgery After Oxervate Use

FDA reports indicate that at least 45 individuals who used Oxervate prescription eye drops subsequently required corneal transplant surgery due to severe complications from the treatment.

These complications, including significant corneal deposits and ulcers, often necessitate surgical intervention to restore vision and maintain the eye’s structural integrity.

Keratoplasty

This surgical procedure involves replacing damaged or diseased corneal tissue with healthy tissue from a donor. Depending on the severity and depth of the corneal damage, the surgery may be a full-thickness transplant (penetrating keratoplasty) or a partial-thickness transplant (lamellar keratoplasty).

Keratoplasty is typically considered when corneal ulcers result in deep scarring that severely affects vision or when ulcers do not respond to medical treatments and pose a risk of corneal perforation. It is also performed when extensive corneal deposits severely distort vision and cannot be corrected through less invasive methods.

Keratoprosthesis

Keratoprosthesis involves the implantation of an artificial cornea and is primarily recommended for patients who are unsuitable for traditional corneal transplantation or who have experienced multiple unsuccessful corneal transplants. This procedure is usually reserved for severe cases where the corneal tissue is too damaged or diseased to sustain a natural donor graft. Such scenarios include recurrent severe corneal ulcers that have caused multiple scars, persistent infections, or where the corneal structure is critically compromised.

Rising Concerns About Corneal Complications Linked to Oxervate

A growing number of reports to the FDA and recent medical studies have expressed concerns about side effects related to corneal deposits and ulcers from Oxervate use. These side effects include serious ocular events that are not currently listed on the drug’s labeling.

Calcium Deposits Causing Vision Issues After Oxervate Treatment

A case series documented in Cornea in January 2022 observed five patients treated with Oxervate for stage 2 or 3 neurotrophic keratitis who developed rapid corneal opacity, indicative of calcium deposits.

Despite discontinuing the treatment, the deposits did not resolve. The interventions varied, with one patient undergoing a superficial layer removal and chemical treatment, another receiving a corneal transplant, and a third fitted with a Boston keratoprosthesis.

Contact Lens Complications with Oxervate

According to a case report in the American Journal of Ophthalmology from May 2022, a patient experienced a significant accumulation of deposits on the surface of her eye during an eight-week treatment with Oxervate.

The deposits, although loosely attached, reformed quickly with each replacement of the bandage contact lens, suggesting a consistent reoccurrence that highlights a potential link between Oxervate use and the formation of ocular surface deposits.

Unexpected Corneal Plaque Development Post-Oxervate Therapy

In a November 2023 case study published in the medical journal Cornea, researchers described the experiences of a 72-year-old male who showed unexpected formation of a thick, white corneal plaque 22 days after starting treatment with Oxervate, despite his initial persistent epithelial defect healing successfully.

This development required surgical intervention to remove the adherent plaque, highlighting another serious complication associated with the drug.

Are there any costs to hire an Oxervate lawyer?

There are absolutely no out-of-pocket costs to review your case or hire our attorneys. Oxervate lawsuits are evaluated for individuals throughout the United States, and all cases are handled on a contingency fee basis.

Through the use of contingency attorney fees, individuals have access to the experience and resources of our national law firm for their potential Oxervate lawsuit — regardless of their individual financial resources.