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For the treatment of all stages of neurotrophic keratitis (NK)

Prescribing Information
OXERVATE® (cenegermin-bkbj ophthalmic solution) 0.002% (20 mcg/mL) Resolutionary Care logo
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Nerves in the shape of a drop

A UNIQUE MOA TARGETS CORNEAL NERVE DAMAGE, THE UNDERLYING CAUSE OF NK1-4

Mechanism of Action

The active ingredient in OXERVATE® is a recombinant form of human nerve growth factor (NGF)1

Cenegermin-bkbj is structurally identical to human NGF protein made in ocular tissues5

Cenegermin-bkbj illustration

Cenegermin-bkbj

Endogenous NGF illustration

Endogenous NGF

Watch a video about how OXERVATE® targets neurotrophic keratitis (NK)

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howngf-works-bg2 Close-up of the nerves at the bottom of the drop of liquid ngf-lens-accent-graphic
How NGF Works

Nerve growth factor (NGF) is an endogenous protein involved in the differentiation and maintenance of neurons1

Endogenous NGF supports corneal integrity through 3 mechanisms contributing to ocular surface homeostasis (shown in preclinical models)1-4,6:

  • Corneal innervation
  • Tear secretion
  • Epithelial cell growth

As part of ocular surface homeostasis, corneal epithelial cells produce NGF to support sensory nerve health, and sensory nerves produce neuromediators to support corneal epithelial cell health.3,4

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For US healthcare professionals only.

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. Other adverse reactions occurring in 1% to 10% of OXERVATE patients and more frequently than in the vehicle-treated patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation and tearing.

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]. Boston, MA; Dompé U.S. Inc.; 2019. 2. Mastropasqua L, Lanzini M, Dua HS, et al. In vivo evaluation of corneal nerves and epithelial healing after treatment with recombinant nerve growth factor for neurotrophic keratopathy. Am J Ophthalmol. 2020;217:278-286. 3. Pedrotti E, Bonacci E, Chierego C, et al. Eight months follow-up of corneal nerves and sensitivity after treatment with cenegermin for neurotrophic keratopathy. Orphanet J Rare Dis. 2022;17:1-8. 4. Mastropasqua L, Massaro-Giordano G, Nubile M, Sacchetti M. Understanding the pathogenesis of neurotrophic keratitis: the role of corneal nerves. J Cell Physiol. 2017;232:717-724. 5. Voelker R. New drug treats rare, debilitating neurotrophic keratitis. JAMA. 2018;320:1309. 6. Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014;8:571-579.