FDA-filed SPL labeling · retrieved through openFDA

Cenegermin-bkbj Ophthalmic

Cenegermin-bkbj is a lab-made form of human nerve growth factor used as eye drops to treat neurotrophic keratitis, a serious condition where the cornea loses sensation and struggles to heal.

Brand name Oxervate
Drug class Recombinant Human Nerve Growth Factor
Rx Form 1 Route Ophthalmic
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveFeb 5, 2025
AvailabilityRx
Earliest approval/marketing year 2018
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 24, 2026
Cenegermin-bkbj Ophthalmic at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Oxervate (cenegermin-bkbj) eye drops are the first treatment of their kind — a lab-made nerve growth factor that helps repair and protect the cornea in people with neurotrophic keratitis. It is used six times a day for eight weeks and is generally well tolerated, with eye pain being the most common side effect. Follow the storage and dosing steps carefully, and always remove contact lenses before each dose.

📖 Cenegermin-bkbj Ophthalmic: Patient Information Guide

A plain-language walkthrough of Cenegermin-bkbj Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Cenegermin-bkbj ophthalmic is approved for one specific eye condition:

  • Neurotrophic keratitis: Oxervate ophthalmic solution 0.002% is indicated for the treatment of this rare corneal disease, in which the cornea loses sensation due to nerve damage, impairing its ability to heal. It is approved for use in adults and children 2 years of age and older.
⚙️How it works

Nerve growth factor (NGF) is a protein your body naturally produces to help develop and maintain nerves, including those that supply the cornea. In neurotrophic keratitis, this nerve support breaks down. Cenegermin-bkbj is a recombinant (lab-made) copy of human NGF. When placed on the eye, it binds to specific high-affinity receptors (TrkA) and low-affinity receptors (p75NTR) in the front of the eye, restoring the nerve signaling that supports corneal health and helps the surface heal.

💊How it's taken

Oxervate is used as eye drops instilled directly into the affected eye(s). The standard course is one drop six times per day, spaced two hours apart, for eight weeks.

  • Remove contact lenses before each dose; reinsert 15 minutes after.
  • If using other eye drops, wait at least 15 minutes between products. Always use Oxervate before any eye ointment or gel.
  • If you miss a dose, skip it and continue with your next scheduled dose as usual — do not double up.
  • Setting an alarm every two hours can help you stay on schedule.
🤒Side effects — in detail

The most common side effects seen in clinical trials include:

  • Eye pain after putting in the drop (reported in about 16% of patients; can be a sign the cornea is healing)
  • Redness of the eye (ocular hyperemia)
  • Eye inflammation
  • Increased tearing
  • Foreign body sensation
  • Sensitivity to light (photophobia)
  • Headache
  • Corneal deposits

After the product became available on the market, additional reports included eye irritation, eyelid inflammation (blepharitis), eyelid swelling or crusting, and new blood vessel growth in the cornea (corneal neovascularization). Contact your doctor right away if any eye reaction feels more serious than mild discomfort.

⚠️Warnings & precautions
  • Contact lenses: Always remove contact lenses before using Oxervate. Wearing a lens during instillation could block the medication from reaching the full corneal lesion. Wait 15 minutes before reinserting them.
  • Eye discomfort: Mild to moderate eye pain during treatment is possible and can be a normal part of healing. If you experience anything beyond mild discomfort, let your doctor know promptly.
🔀What it interacts with

The Oxervate label does not identify specific drug–drug interactions, but does note the following when using multiple eye products together:

  • If using more than one topical eye product, space them at least 15 minutes apart to avoid diluting Oxervate.
  • Always use Oxervate before applying any eye ointment, gel, or other thick eye drop — otherwise those products can wash Oxervate away.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Contact lens wearers: Lenses must come out before each dose and stay out for 15 minutes — this applies to both corrective and therapeutic lenses.
  • Pregnancy: There are no human data on Oxervate use during pregnancy. Animal studies at very high doses showed some fetal effects, but at doses far above what is used in the eye. Discuss risks and benefits with your doctor.
  • Breastfeeding: It is not known whether cenegermin-bkbj passes into breast milk. Talk to your doctor to weigh the benefits of breastfeeding against any potential risk.
  • Children: Oxervate is established as safe and effective in pediatric patients from 2 years of age and older.
  • Older adults: Adults 65 and older showed no differences in safety or effectiveness compared to younger patients in clinical studies.
  • No contraindications: The FDA label lists no contraindications for Oxervate.
🔬Pharmacokinetics — how your body processes it

Researchers measured blood levels of nerve growth factor (NGF) in 20 healthy volunteers who used Oxervate up to six times a day. Most participants had NGF levels below the detectable limit before treatment started, suggesting that ophthalmic use of cenegermin-bkbj does not meaningfully raise its levels in the bloodstream at the doses used in the eye.

📦How to store it

Store the weekly cartons containing OXERVATE vials in the freezer at or below -4°F (-20°C). Within 5 hours of delivery, store the weekly carton(s) containing OXERVATE vials in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 14 days.

📄 Written from Cenegermin-bkbj Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Cenegermin-bkbj Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is neurotrophic keratitis, and why do I need this medication?
Neurotrophic keratitis is a condition where the nerves supplying your cornea — the clear front part of your eye — become damaged. Without those nerve signals, your cornea can't feel pain or heal itself properly, which can lead to serious eye damage over time. Oxervate is a lab-made copy of a natural protein your body uses to maintain those nerves. It helps your cornea heal by restoring the nerve support it's been missing.
Why do I have to use these drops six times a day? That seems like a lot.
The six-times-a-day schedule, every two hours, is the regimen that was tested in clinical trials and shown to work. It keeps a steady supply of the nerve growth factor on the surface of your eye throughout the day. Setting phone alarms every two hours is a practical way to stay on track — the dosing card that comes with your supply can also help you keep a record.
My eye hurts after I put the drops in. Is that normal?
Yes, eye pain after instillation is the most common side effect and was reported by about 1 in 6 people in the clinical trials. It's often a sign that the cornea is healing, which is actually what you want to see. That said, if the pain feels severe, gets worse over time, or you notice something more alarming like significant swelling or vision changes, call your doctor right away — don't wait.
Do I need to do anything special with the vials to store and prepare them?
Yes — Oxervate is stored frozen at the pharmacy, so when you pick up your weekly supply, you need to put it in your refrigerator within 5 hours. Each day, take out one vial in the morning, let it thaw (up to 30 minutes at room temperature), and follow the step-by-step preparation instructions that come with it. Don't shake the vial. Each vial is good for up to 12 hours after you connect the adapter, and you must throw it away at the end of each day even if solution is left.
Can I still wear my contact lenses while using Oxervate?
Yes, but you have to take them out before every single dose. Contact lenses can block the medication from spreading evenly across the damaged area of your cornea. You can put your lenses back in 15 minutes after using the drops. This applies whether you wear lenses for vision correction or for therapeutic reasons.
Is Oxervate safe to use if I'm pregnant or breastfeeding?
There are no human studies on Oxervate during pregnancy or breastfeeding, so the honest answer is that we don't have enough data to say for certain. Animal studies at extremely high doses — far higher than what you'd receive as eye drops — showed some effects on fetuses, but those findings may not apply to humans. If you're pregnant, trying to become pregnant, or breastfeeding, have a candid conversation with your doctor so you can weigh the benefits of treating your eye condition against any potential risk.
Is Cenegermin-bkbj Ophthalmic available over the counter?
Cenegermin-bkbj Ophthalmic is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Cenegermin-bkbj Ophthalmic first available?
Cenegermin-bkbj Ophthalmic has been available in the United States since at least 2018, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cenegermin-bkbj Ophthalmic?
Cenegermin-bkbj Ophthalmic is supplied by 3 manufacturers listed in the FDA NDC Directory, including Domp farmaceutici S.p.A., Domp, Domp� farmaceutici S.p.A..

💬 Answers drafted from Cenegermin-bkbj Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Cenegermin-bkbj Ophthalmic comes

Cenegermin-bkbj Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Eye drops

In the eye
Brands Oxervate
How this form is used
What it may be used for
  • Oxervate eye drops are used to treat neurotrophic keratitis in adults and children aged 2 years and older
Important instructions
  • Oxervate is instilled as one drop in the affected eye(s) six times a day, every two hours, for eight weeks
  • Oxervate vials are stored frozen at the pharmacy; once you receive your weekly supply, refrigerate within 5 hours and use within 14 days
  • Remove contact lenses before each Oxervate dose and wait 15 minutes before reinserting them
  • If using other eye drops or ointments, use Oxervate at least 15 minutes before them; use Oxervate before any eye ointment or gel
Available strengths 1 strength
4 FDA-listed product records

📊 Cenegermin-bkbj Ophthalmic across the U.S. market

How Cenegermin-bkbj Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
3
Manufacturers
1
Brand names
4
FDA-listed product records
2018
First marketed
Domp farmaceutici S.p.A.50%
Domp25%
Domp� farmaceutici S.p.A.25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Cenegermin-bkbj Ophthalmic is used

A general measure of how commonly Cenegermin-bkbj Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cenegermin-bkbj Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

1,558
Medicaid prescriptions filled (Q1–Q4 2025)
$66.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cenegermin-bkbj Ophthalmic prescribed? Of the 1,596 medications we measure, Cenegermin-bkbj Ophthalmic ranks #1,220 by Medicaid prescriptions — more than 24% of them.

Where Cenegermin-bkbj Ophthalmic ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cenegermin-bkbj Ophthalmic product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

cenegermin-bkbj 0.02 MG/ML Ophthalmic Solution

1,558 Medicaid prescriptions (Q1–Q4 2025) 100% of Cenegermin-bkbj Ophthalmic prescriptions shown $66.4M gross reimbursement (before rebates) ≈ $42,627 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2104336

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cenegermin-bkbj Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Cenegermin-bkbj Ophthalmic NDCs with Medicaid activity.

🔍 Compare Cenegermin-bkbj Ophthalmic products

A representative set of FDA-listed product records for Cenegermin-bkbj Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Eye drops
20 mcg/mL Ophthalmic Domp BLA View NDC →
20 mcg/mL Ophthalmic Domp farmaceutici S.p.A. × 2 listings BLA View NDC →
20 mcg/mL Ophthalmic Domp� farmaceutici S.p.A. BLA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Cenegermin-bkbj Ophthalmic NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cenegermin-bkbj Ophthalmic RxCUI 2104332 1 dose form · 1 strength
  1. Dose form (SCDF) Ophthalmic Solution RxCUI 2104335 In current FDA listings
    Clinical drug / strength (SCD) bkbj 0.02 MG/ML RxCUI 2104336

Look up RxCUI 2104332 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Oxervate

🏭 Manufacturers & labelers

Domp farmaceutici S.p.A. 2 Domp 1 Domp� farmaceutici S.p.A. 1

RxNorm drug class

Cenegermin-bkbj Ophthalmic belongs to the Recombinant Human Nerve Growth Factor class.

Pharmacologic class Recombinant Human Nerve Growth Factor
Drug family (ATC) Other ophthalmologicals

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 5, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cenegermin-bkbj Ophthalmic.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Cenegermin-bkbj Ophthalmic after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
3
Linked representative label
Domp farmaceutici S.p.A.
Linked label effective
Feb 5, 2025
Composite sections available
20
Linked SPL Set ID
89e4bfec-d710-40ed-8885-5d13ba46b1cd
Linked SPL Document ID
a8f6e6a2-a76e-4e1b-b747-989811528a09
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Domp farmaceutici S.p.A. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.