OXERVATE® is a prescription eye drop solution used to treat a condition called neurotrophic keratitis. OXERVATE is safe and effective in children two years of age and older.
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What is OXERVATE®?

The only prescription eye drop FDA‑approved to treat neurotrophic keratitis.

WHAT IS OXERVATE

What is OXERVATE

The only prescription eye drop FDA-approved to treat neurotrophic keratitis (NK)

The active ingredient in OXERVATE® is cenegermin-bkbj

Cenegermin-bkbj is a manufactured form of a natural protein in the body called nerve growth factor (NGF).

CLINICAL TRIAL RESULTS

In 2 clinical trials, 151 patients with neurotrophic keratitis (NK) were treated with OXERVATE or placebo (inactive substance) for 8 weeks.

Percentage of patients that experienced complete corneal healing with OXERVATE vs placebo at 8 weeks*

Results of treatment with OXERVATE vs placebo at 8 weeks in two NK clinical trialsResults of treatment with OXERVATE vs placebo at 8 weeks in two NK clinical trials

*At 8 weeks, each patient’s degree of corneal healing was determined by a test to assess damage to the cornea (corneal staining). If there was no staining in the damaged part of the cornea, and no persistent staining in the rest of the cornea, the cornea was considered completely healed (complete corneal healing).

More patients who received OXERVATE experienced complete corneal healing compared to those who received placebo (72% vs 33% and 65% vs 17%).

The most common side effect with OXERVATE was eye pain (~16%). Other side effects with OXERVATE, in 1% to 10% of patients, included corneal deposits, feeling of having something in the eye, enlarged blood vessels in the white of the eyes, swelling of the eye, sensitivity to light, increase of tears, and headache.

SAFETY

OXERVATE side effects

What are the possible side effects of OXERVATE?

  • The most common side effects of OXERVATE are eye pain, corneal deposits, feeling of having something in the eye, enlarged blood vessels in the white of the eyes, swelling of the eye, sensitivity to light, increase of tears, and headache
  • These are not all the possible side effects of OXERVATE
  • Tell your doctor if you have any side effects that bother you or do not go away

This image is for illustrative purposes only. This is not an exact representation of a patient.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088

General information about the safe and effective use of OXERVATE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OXERVATE for a condition for which it was not prescribed. Do not give OXERVATE to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or doctor for information about OXERVATE that is written for health professionals.

For more information about OXERVATE talk to your doctor or pharmacist.

TALKING TO YOUR DOCTOR

Get the conversation started

You may have questions when you’re prescribed OXERVATE.

Download the OXERVATE Brochure and use the Doctor Discussion Guide within during your next appointment.

GET THE DOCTOR DISCUSSION GUIDE

More Resources

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ALL FIELDS REQUIRED

Important Safety Information

Before you use OXERVATE, tell your doctor about all of your medical conditions, including if you:

  • have an infection in your eye. If you get an eye infection while using OXERVATE, talk to your doctor right away.
  • are pregnant or plan to become pregnant. It is not known if OXERVATE will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if OXERVATE passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use OXERVATE.

How should I use OXERVATE?

  • Use 1 drop of OXERVATE in the affected eye or both eyes if needed, 6 times each day, about 2 hours apart starting in the morning. Continue your treatment for 8 weeks.
  • If you use any other eye drops, wait at least 15 minutes before or after using OXERVATE. This will help to avoid one eye drop diluting the other eye drop.
  • If you also use an eye ointment or gel or an eye drop that is thick, use OXERVATE first, and then wait at least 15 minutes before using the other eye ointment, gel, or drops.
  • If you wear contact lenses in your affected eye or both eyes remove them before using OXERVATE and wait 15 minutes after using OXERVATE before reinserting them.
  • Do not use other eye medicines without talking to your doctor.
  • Talk to your doctor first before you stop using OXERVATE.

What should I avoid while using OXERVATE?

  • Your vision may be blurred for a short time after using OXERVATE. If this happens, wait until your vision clears before you drive or use machines.

What are the possible side effects of OXERVATE?

  • The most common side effect of OXERVATE is eye pain, enlarged blood vessels in the white of the eyes, swelling of the eye, and increase of tears.

Tell your doctor if you have any side effects that bother you. These are not all the possible side effects of OXERVATE.

For more information about OXERVATE talk to your healthcare provider or pharmacist.

To report ADVERSE REACTIONS, contact Dompé U.S. Inc. at 1-833-366-7387 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.

What is OXERVATE?

  • OXERVATE is a prescription eye drop solution used to treat a condition called neurotrophic keratitis.

Please see full Prescribing Information and Patient Information for OXERVATE.