Why it matters
Dompé notes untreated NK may progress to a corneal ulcer, an open sore in the cornea.
OXERVATEMedical Eye Care · Prescription
OXERVATE Cenegermin-bkbj for neurotrophic keratitis.
OXERVATE (cenegermin-bkbj) ophthalmic solution 0.002% is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis. Identifying the disease early, and knowing how the eight-week course works, lets a practice treat or refer with confidence.
0.002%cenegermin-bkbj, 20 mcg/mL
6 timesdaily, about 2 hours apart
8 weekscourse of treatment
72%complete corneal healing at week 8 in NGF0212
The disease and the drug
Restoring corneal healing
Neurotrophic keratitis follows damage to corneal nerves, which impairs healing and can lead to persistent epithelial defects and ulcers. Cenegermin is a recombinant form of nerve growth factor.
Corneal sensation
Reduced sensation is the core finding; an esthesiometer documents it objectively.
EsthesiometryHealing rates
Complete healing at week 8 was 72% versus 33.3% on vehicle in NGF0212, and 65.2% versus 16.7% in NGF0214.
LabelRecurrence
Among healed patients, recurrence was about 20% in NGF0212 and 14% in NGF0214.
LabelHow the course works
The regimen is demanding, so set expectations at the first visit.
- One drop six times daily
- Weekly carton of seven vials
- Eight-week course
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Dosing
One drop in the affected eye or eyes six times a day at two-hour intervals for eight weeks.
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Supply
Weekly cartons of seven multiple-dose vials ship in an insulated pack with a delivery system kit of adapters, pipettes and wipes.
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Storage
Pharmacies keep it frozen. After dispensing it is refrigerated for up to 14 days; an opened vial is discarded after 12 hours.
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Contact lenses
Remove lenses before dosing and wait 15 minutes before reinserting.
In the clinic
From suspicion to treatment
Patients often have fewer symptoms than their staining suggests, because sensation is reduced.
Suspect
Think of NK with persistent epithelial defects, a history of herpes, diabetes, corneal surgery or trigeminal injury, and reduced corneal sensation.
Confirm
Document staining and test corneal sensation. Stop toxic or preserved drops where you can.
Treat
Prescribe the eight-week course through the specialty pharmacy, train the patient on the kit, and follow healing closely.
Indication and safety
Indication
OXERVATE (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.
Warnings and precautions
- Contact lenses should be removed before application and may be reinserted 15 minutes after dosing
- Mild to moderate eye discomfort such as eye pain may occur; patients should contact their doctor if a more serious reaction occurs
- Contraindications: none
Most common adverse reactions
- Eye pain, about 16%
- Ocular hyperemia, eye inflammation and increased lacrimation
- Corneal deposits and foreign body sensation in 1% to 10%
Product details
| Strength | 0.002% (20 mcg/mL) |
|---|---|
| Dosage form | Multiple-dose vial, ophthalmic solution |
| Pack | Weekly carton of 7 vials with a delivery system kit |
| Manufacturer | Dompé U.S. Inc. |
| Initial US approval | 2018 |
Questions doctors ask about OXERVATE
What is the indication?
Treatment of neurotrophic keratitis.
What is the dosing schedule?
One drop in the affected eye or eyes six times daily at two-hour intervals for eight weeks.
How effective was it in trials?
Complete corneal healing at week 8 was 72% versus 33.3% on vehicle in NGF0212, and 65.2% versus 16.7% in NGF0214.
What is the most common side effect?
Eye pain, reported in about 16% of patients.
How is it stored?
Frozen at the pharmacy, then refrigerated after dispensing for up to 14 days. An opened vial is used for one day and discarded after 12 hours.
How do I confirm reduced corneal sensation?
Esthesiometry. See the corneal sensation testing page for a non-contact option.
References
Catch neurotrophic keratitis early
Test corneal sensation in patients at risk, and know the treatment path before you need it.
OXERVATE is a trademark of Dompé farmaceutici S.p.A. Written for licensed eye care professionals. Review the full Prescribing Information before prescribing. Individual results vary.