Table of contents
- Latest Oxervate Lawsuit Updates
- September 10, 2026: DOJ Announces Dompé Settlement
- November 27, 2023: Cornea Report Describes Corneal Plaque
- August 28, 2023: Study Analyzes FDA Adverse Event Reports
- May 14, 2022: Case Report Describes Contact Lens Deposits
- January 1, 2022: Cornea Case Series Reports Calcific Band Keratopathy
- What Is Oxervate?
- Who May Be Affected?
- Reported Injuries or Damages
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- Does Oxervate Restore Vision?
- What Does the Research Say About Oxervate Corneal Deposits?
- How Do I Report Oxervate Side Effects?
- Did Dompé Settle with the Government?
Oxervate (cenegermin-bkbj) eye drops treat neurotrophic keratitis, and published reports describe corneal deposits and plaques in some patients who used them. The drug label lists corneal deposits among adverse reactions reported in clinical trials.
No injury lawsuit, class action or MDL names Oxervate. As of October 2026, no recall has been announced. Dompé U.S. Inc. makes it, and its Italian parent, Dompé farmaceutici S.p.A., holds the European Union marketing authorisation.
A September 10, 2026 Justice Department settlement with the company concerns Medicare co-pay payments, not eye injuries. Published case reports cannot show that the drug caused the deposits.
Latest Oxervate Lawsuit Updates
September 10, 2026: DOJ Announces Dompé Settlement
The U.S. DOJ announced that Dompé U.S. Inc. agreed to pay $32 million. It resolves allegations that, between 2018 and 2021, it paid Medicare beneficiary co-pays through two patient assistance foundations to induce Oxervate purchases [1].
The release says the claims are allegations only, with no determination of liability. The matter concerns co-pay payments, not eye injuries.
November 27, 2023: Cornea Report Describes Corneal Plaque
Surico and colleagues published a report in Cornea on a 72-year-old man with mucous membrane pemphigoid, limbal stem cell deficiency and neurotrophic keratopathy [2]. A white, thick corneal superficial plaque formed on day 22 of Oxervate treatment.
The drug was stopped and the plaque was carefully removed. There was no recurrence. The report describes one patient and cannot show the drug was the cause.
August 28, 2023: Study Analyzes FDA Adverse Event Reports
Li and colleagues published a study of the FDA adverse event reporting system in Expert Opinion on Drug Safety [3]. It covered 2018 to 2022.
It identified 3288 cases of cenegermin-related ocular adverse events and 56 positive ocular-related signals, 50 of them unexpected. Median onset was 6 days. The study cannot prove the drug caused the events.
May 14, 2022: Case Report Describes Contact Lens Deposits
White and Affeldt published a case report in the American Journal of Ophthalmology Case Reports [4]. A patient with stage III neurotrophic keratitis was treated with topical cenegermin.
Drug precipitate deposits formed on the ocular surface and a bandage contact lens over eight weeks. The patient was unaware of them. The authors suggest such deposits may be an esthetic issue only.
January 1, 2022: Cornea Case Series Reports Calcific Band Keratopathy
Qureshi and colleagues published a Cornea multicenter case series on acute calcific band keratopathy [5]. It described five patients from three institutions who were treated with cenegermin.
The deposits were visually significant in all patients. The authors urged close monitoring because the corneal opacity may be irreversible and may require keratoplasty.
What Is Oxervate?
According to the manufacturer, Oxervate is a prescription eye drop used to treat neurotrophic keratitis. Its active ingredient, cenegermin-bkbj, is a man-made form of a natural body protein called nerve growth factor.
According to NORD, neurotrophic keratitis is a rare eye disorder that affects the cornea, the clear outer layer at the front of the eye [6].
Who May Be Affected?
People with neurotrophic keratitis who were treated with Oxervate eye drops may be affected. The Oxervate label directs 1 drop six times daily in the affected eye for 8 weeks [7].
Eligibility cannot be judged from a web page. Only an individualized legal review of your own records can say whether your situation fits.
Reported Injuries or Damages
The findings below come from the label and medical journals. They are reported findings. They are not lawsuit allegations or court findings.
The label lists corneal deposits among reactions in 1% to 10% of Oxervate patients. In two clinical trials, 101 patients received cenegermin-bkbj. The most common reaction was eye pain after instillation, in about 16% of patients.
Because postmarketing reports come from a group of unknown size, the label says the frequency and any causal link cannot always be estimated.
The Cornea case series described a white corneal opacity. It looked like calcium deposits and did not clear after the drug was stopped. One patient had superficial keratectomy with EDTA chelation. One had penetrating keratoplasty, and one a Boston keratoprosthesis.
The authors of the adverse event study note that painful epithelial plaques and irreversible corneal deposits have been reported. They recognized 20 events as important medical events, including corneal perforation, eye infection, corneal deposits and eye inflammation.
The European Medicines Agency lists Oxervate as authorised in the European Union, according to its European public assessment report [8].
Evidence to Preserve
Keep records that show your Oxervate use and eye problems, such as:
- Prescription and pharmacy records showing the Oxervate dates and dose
- The box, label and lot or batch information
- Medical records and eye exam notes from before, during and after treatment
- Photographs of the eyes or any visible change
- Records of other eye drops, contact lenses or procedures
- Receipts and insurance statements
- A symptom log and any messages with the prescriber or the maker
Filing Deadlines
State law sets the time limit for an injury claim. That limit changes with your state, the injury date and the diagnosis date.
In some states, the time starts at diagnosis. A missed limit can end a claim, even when the facts are strong and the injury is real. Talk to a lawyer soon about the limit that applies to you.
Frequently Asked Questions
Does Oxervate Restore Vision?
Oxervate is not described as restoring vision. In two trials, complete corneal healing at 8 weeks was 72% vs 33% and 65% vs 17% against placebo. NORD says neurotrophic keratitis can lead to permanent loss of vision if not properly treated.
What Does the Research Say About Oxervate Corneal Deposits?
The research on Oxervate corneal deposits so far is case reports and one adverse event database study. The Cornea case series authors could not identify any risk factors. Reports like these do not show that the drug caused the deposits.
How Do I Report Oxervate Side Effects?
You can report Oxervate side effects to the FDA at 1-800-FDA-1088. The manufacturer also says to tell your doctor about any side effects that bother you or do not go away.
Did Dompé Settle with the Government?
Dompé settled with the government through the Justice Department. The U.S. Attorney’s Office for the District of Massachusetts handled the matter. Dompé farmaceutici S.p.A. self-disclosed the conduct to the United States, according to the Justice Department’s release.