Important Safety Information Prescribing Information
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OXERVATE® (cenegermin-bkbj)
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Important Safety Information Prescribing Information Dompé Site Patient Site
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MECHANISM OF ACTION

OXERVATE® Works Beyond the Ocular
Surface to Support Corneal Nerve Health1

OXERVATE is structurally identical to nerve growth factor (NGF)2

OXERVATE1

Addresses the underlying nerve
damage that drives neurotrophic
keratitis (NK) progression through a
recombinant human nerve growth
factor (rhNGF).

NGF1,3

Endogenous NGF supports corneal
nerve integrity and contributes to
ocular surface homeostasis.*

NGF supports:

  • Corneal integrity
  • Tear secretion
  • Epithelial cell growth

    OXERVATE addresses the root of NK: nerve damage
    or dysfunction, which can lead to complete corneal healing
    in patients with NK.1,3

    *Based on preclinical models.3

    OXERVATE is delivered via eye drop,1
    a method your patients may be familiar with

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    Indication and Important Safety Information

    WARNINGS AND PRECAUTIONS

    Use with Contact Lens
    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

    Eye Discomfort
    OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

    ADVERSE REACTIONS
    In clinical trials, the most common adverse reaction was eye pain following instillation which was reported in approximately 16% of patients. Eye pain may arise as corneal healing occurs. Other adverse reactions occurring in 1% to 10% of OXERVATE patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache.

    USE IN SPECIFIC POPULATIONS

    Pregnancy
    There are no data from the use of OXERVATE in pregnant women to inform any drug associated risks.

    Lactation
    The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for OXERVATE, and any potential adverse effects on the breastfed infant from OXERVATE.

    Pediatric Use
    The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in pediatric patients 2 years of age and older is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in children.

    INDICATION
    OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) is indicated for the treatment of neurotrophic keratitis.

    DOSAGE AND ADMINISTRATION
    Instill one drop of OXERVATE in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks.

    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.

    Please see full Prescribing Information for OXERVATE.

    References: 1. OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) [US package insert]. San Mateo, CA: Dompé U.S. Inc.; 2024. 2. Voelker R. New drug treats rare, debilitating neurotrophic keratitis. JAMA. 2018;320(13):1309. 3. Mastropasqua L, Massaro-Giordano G, Nubile M, Sacchetti M. Understanding the pathogenesis of neurotrophic keratitis: the role of corneal nerves. J Cell Physiol. 2017;232(4):717-724.

    Indication and Important Safety Information

    OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) is indicated for the treatment of neurotrophic keratitis.

    WARNINGS AND PRECAUTIONS

    Use with Contact Lens
    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

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