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Oxervate FDA Approval History

Reviewed by J.Stewart B.Pharm. Last updated on Aug 22, 2018.

FDA Approved: Yes (First approved August 22, 2018)
Brand name: Oxervate
Generic name: cenegermin-bkbj
Dosage form: Ophthalmic Solution
Company: Dompé farmaceutici SpA
Treatment for: Neurotrophic Keratitis

Oxervate (cenegermin) is a recombinant human nerve growth factor (rhNGF) ophthalmic solution indicated for the treatment of neurotrophic keratitis.

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 your doctor right away.
  • are using any other eye drops.
  • wear contact lenses.
  • 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.

Tell your doctor about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements.

How should I use Oxervate?

  • See the complete Instructions for Use supplied with your prescription for detailed instructions about the right way to use Oxervate.
  • Use Oxervate exactly as your doctor tells you.
  • Use one drop of Oxervate in the affected eye or both eyes if needed, six times each day, about two 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.
  • If you miss a dose of Oxervate, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose.
  • Do not use other eye medicines without talking to your doctor.
  • Talk to your doctor first before you stop using Oxervate.
  • If you have any questions about how to use Oxervate, ask your doctor or pharmacist.

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.

Oxervate side effects
The most common side effect of Oxervate is eye pain, excess blood in the white of the eyes (ocular hyperemia), swelling (inflammation) of the eye, and increase of tears (increased lacrimation).

What are the ingredients in Oxervate?
Active ingredient: cenegermin-bkbj
Inactive ingredients: disodium hydrogen phosphate anhydrous, hydroxypropylmethyl cellulose, L-methionine, mannitol, polyethylene glycol 6000, sodium dihydrogen phosphate dihydrate, trehalose dihydrate, Water for Injection, USP, and hydrochloric acid and/or sodium hydroxide to adjust pH.

Development Timeline for Oxervate

Aug 22, 2018Approval FDA Approves Oxervate (cenegermin) for Neurotrophic Keratitis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.