What is OXERVATE®?

The only prescription eye drop FDA‑approved to treat people with neurotrophic keratitis (NK).

OXERVATE & NGF

The active ingredient in OXERVATE is
cenegermin-bkbj

Cenegermin-bkbj is a manufactured protein that is identical to a protein your eye creates naturally. This protein is called nerve growth factor (NGF).

The structure of the active ingredient in OXERVATE

Cenegermin-bkbj manufactured

A nerve growth factor protein

Nerve growth factor (NGF) made in your body

What does your body’s NGF do?

In a healthy eye, NGF helps your cornea and corneal nerves stay healthy.

NGF plays an important role in the development and survival of nerve cells

Maintains healthy function of corneal nervesA healthy eye and corneal nervesA healthy eye and corneal nervesSupports the health of corneal cells
CLINICAL TRIAL RESULTS

Complete corneal healing for most people with NK

In the clinical trials, patients with NK were treated with OXERVATE® or placebo for 8 weeks

Up to 72% of patients taking OXERVATE achieved complete corneal healing

Treatment success criteria at 8 weeks

After 8 weeks, each patient’s degree of healing was determined by a doctor by staining the cornea. 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.

80% of patients who achieved complete corneal healing remained completely healed at 1 year

Treatment success criteria at 1 year

At a follow-up visit 48 weeks after the treatment period, patients in the REPARO trial who were completely healed were evaluated by a doctor again. If staining in the cornea was less than 0.5 mm in size, the cornea was considered to have remained completely healed.

Doctors use corneal staining to assess the amount of corneal tissue damage.

The greater the amount of stain, the more tissue damage.

In REPARO (Study NGF0212), 101 patients with NK in 1 eye were evaluated.

  • 72% of the patients treated with OXERVATE and 33.3% of the patients treated with placebo achieved complete corneal healing
  • Patients had a follow-up visit 48 weeks after completing treatment

In Study NGF0214, 47 patients with NK in 1 or both eyes were evaluated.

  • 65.2% of the patients treated with OXERVATE and 16.7% of the patients treated with placebo achieved complete corneal healing
  • Patients had a follow-up visit 24 weeks after completing treatment
SAFETY

OXERVATE side effects

You may experience side effects while using OXERVATE®.

An eye with an infection

Before using OXERVATE:

  • Tell your doctor if you have an infection in your eye. If you get an eye infection while using OXERVATE, talk to your doctor right away
A blurry eye

While using OXERVATE:

  • OXERVATE may cause mild to moderate eye discomfort such as eye pain during your treatment
  • 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
An eye experiencing pain

What patients in clinical trials have experienced when using OXERVATE:

  • In clinical trials, most side effects reported by patients taking OXERVATE were mild and temporary
  • The most common side effect was eye pain, reported by about 16% of patients
  • Other side effects reported between 1% and 10% of patients treated with OXERVATE were 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

Ask your doctor what side effects you may experience when starting your treatment with OXERVATE

GET THE DOCTOR DISCUSSION GUIDE

TALKING TO YOUR DOCTOR

Get the conversation started

If you’re prescribed OXERVATE you may not know what to expect or feel uncertain about the process. Use these sample questions to help start a conversation with your doctor and get the information you need to feel confident using OXERVATE.

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

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Important Safety Information

What is OXERVATE?

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also contact Dompé U.S. Inc. at 1‑833‑366‑7387.

Please see full Prescribing Information and Patient Information for OXERVATE.