Oxervate Lawsuit: Corneal Deposits, Vision Loss, and Dompé Claims

If you developed corneal deposits, painful plaques, ulcers, or vision loss after using the eye drop Oxervate, product liability attorneys are investigating potential lawsuits against the manufacturer, Dompé, on a failure-to-warn theory. As of mid-2026, no Oxervate lawsuit has actually been filed in court, and at least one firm that had been reviewing cases stopped taking them, while others continue to accept claims nationwide.¹²

Injuries That May Support a Claim

Firms investigating Oxervate (cenegermin-bkbj) claims have focused on patients who used the drops for neurotrophic keratitis and afterward experienced one or more of the following:¹

Corneal deposits
Corneal plaques, including painful adherent plaques
Corneal ulcers
Corneal scarring or thinning
Acute calcific band keratopathy
Vision loss or blindness
The need for a corneal transplant or a Boston keratoprosthesis
Severe eye pain and light sensitivity

Timing matters. In published case reports, complications appeared quickly: a plaque developed 22 days into treatment in one 72-year-old patient, another patient’s plaque emerged at 6.5 weeks, and the median time from starting the drug to an adverse event in a large FDA database review was six days.³⁴⁵

What the Label Warns About, and What It Leaves Out

Oxervate was approved by the FDA on August 22, 2018.⁶ The original prescribing information listed corneal deposits as an adverse reaction occurring in 1% to 10% of patients and described eye discomfort as “mild to moderate.”⁷ It carried no boxed warning.

A revised label dated October 2023 kept the corneal deposits entry and added corneal neovascularization to a new postmarketing experience section.⁸ Even after that update, the label does not warn about corneal plaques, corneal ulcers, acute calcific band keratopathy, or the possibility of vision loss or blindness, and it does not mention that some patients have required corneal transplant surgery.³ Those are precisely the outcomes at the center of the legal investigations.

The Safety Evidence Behind the Claims

Signs of trouble appeared before approval. In the pivotal clinical trial, three of 75 patients in the treatment arm (4%) developed corneal deposits, compared to zero in the control group. FDA reviewers flagged the imbalance and recommended labeling the finding.⁹

Once the drug reached wider use, more severe complications appeared in the medical literature. A January 2022 multicenter case series in Cornea reported five patients who developed white corneal opacities consistent with acute calcific band keratopathy during Oxervate treatment. The deposits appeared within weeks of starting the drug, did not resolve after stopping it, and in one case histopathology showed calcification through 90% of the corneal stroma. One of the five needed a full corneal transplant; another received a Boston keratoprosthesis.¹⁰

Researchers at Massachusetts Eye and Ear later described “painful epithelial plaques and irreversible corneal deposits” tied to Oxervate use.⁵ A June 2024 retrospective review of 46 patients treated between 2021 and 2023 found that five (10.9%) developed acute calcific band keratopathy during treatment or within a month of stopping. All five required surgery. Two patients who tolerated a first course developed calcification after a repeat course.¹¹

A 2024 analysis of the FDA Adverse Event Reporting System (Li et al., published in Expert Opinion on Drug Safety) reviewed 3,288 cenegermin-related ocular adverse event reports from 2018 to 2022. The authors identified 56 statistically significant adverse event signals, and 50 of those were for complications not listed on the label, including corneal perforation, eye infection, corneal deposits, and eye inflammation.⁵ The reporting odds ratio for corneal deposits was 418.67, meaning they were reported at a rate hundreds of times higher than expected relative to other drugs in the database.⁴

By mid-2024, FAERS contained 6,619 total adverse event reports listing cenegermin as a suspect drug, 994 of them classified as serious. More than 591 involved visual impairment ranging from blurred vision to blindness, and at least 45 people reported needing corneal transplant surgery after using the drops.⁴

The Legal Theory Against Dompé

The potential claims are failure-to-warn product liability actions. The core allegation is that Dompé knew or should have known about serious corneal complications and failed to disclose them adequately to patients and prescribing physicians.

Attorneys investigating the claims have pointed to several specific alleged shortcomings:

An early clinical trial signal, with three of 75 treated patients developing corneal deposits versus none in the placebo group, that was noted but not further studied before approval.⁴
A label that has never warned about corneal plaques, corneal ulcers linked to the drug, vision loss or blindness, or the possibility that patients may need transplant surgery, even as those events accumulated in the medical literature and in FAERS.⁵
Language characterizing adverse reactions as “mild to moderate” eye discomfort, which investigators argue does not reflect the painful, sometimes irreversible outcomes documented after approval.⁷
Approval on a limited data set. Oxervate received orphan drug designation in June 2014 and expedited FDA approval in 2018 based on a study of only 75 treated patients, a sample size critics say was too small to surface rarer serious events.¹²

The theory of harm is that patients denied accurate risk information could not weigh Oxervate against alternative treatments, and many say they would have chosen differently had the risks been disclosed.

Where the Litigation Stands

No Oxervate lawsuits have been filed in court as of mid-2026.¹²³¹³ Whether the investigations lead to filed complaints, and whether any filings develop into coordinated or multidistrict litigation, is not yet known.

What to Do If You Were Injured

Preserve everything that documents your treatment and your injury. That means the Oxervate prescription and pharmacy records, your ophthalmology chart notes and imaging showing the deposits, plaques, ulcers, or scarring, records of any transplant or keratoprosthesis surgery, and dated notes on when your symptoms began relative to starting the drops. Because the reported time between starting Oxervate and the appearance of complications has ranged from days to weeks, the treatment timeline is often central to the claim. A product liability attorney investigating cenegermin cases can review those records and tell you whether your injuries fit the profile the current investigations are pursuing.

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FDA. Oxervate Prescribing Information (Revised)
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FDA. Oxervate Clinical Review Summary
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PubMed. Acute Calcific Band Keratopathy as an Adverse Effect of Recombinant Human Nerve Growth Factor (Cenegermin): A Multicenter Case Series
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Investigative Ophthalmology & Visual Science. Acute Calcific Band Keratopathy After Cenegermin Use for Neurotrophic Keratitis
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