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

Prescribing Information

NK is caused by corneal nerve damage1

Corneal nerve damage may lead to a decrease in or total loss of corneal sensitivity—the hallmark of neurotrophic keratitis (NK). This nerve damage impacts ocular surface homeostasis by disrupting the interplay between corneal nerves and corneal epithelial cells, which can lead to epithelial breakdown, including ulceration and, in severe cases, melting and perforation.1

Etiologies

Any injury or systemic condition affecting corneal sensory innervation can lead to NK1-5

Ocular

  • Post-herpetic infection
  • Ocular surgery (eg, LASIK, cataract surgery, corneal transplant, vitrectomy)
  • Chronic ocular surface inflammation or injury
  • Contact lens wear
  • Chronic dry eye disease
  • Topical ophthalmic drug toxicity
  • Chemical and physical burns

Systemic

  • Diabetes
  • Multiple sclerosis
  • Vitamin A deficiency
  • Leprosy
  • Amyloidosis

CNS

  • Post-neurosurgical procedures
  • Stroke
  • Neoplasm
  • Aneurysms
  • Degenerative CNS disorders (eg, Parkinson’s)

Genetic

  • Riley-Day syndrome
  • Goldenhar-Gorlin syndrome
  • Moebius syndrome
  • Familial corneal hypoesthesia

A patient with 1 or more of these conditions or etiologies should prompt suspicion of neurotrophic keratitis (NK)1,2,4,5

Presentation & Signs

Patients with NK may not complain of symptoms due to decreased corneal sensitivity2

Signs and symptoms of neurotrophic keratitis (NK) can include2:

Dryness

Reduced blinking

Photophobia

Blurry vision

Stages

NK is classified into 3 stages of increasing severity*2

Neurotrophic keratitis (NK) is progressive—and if left untreated can lead to severe corneal damage6

Stage 1

Punctate epithelial keratitis (PEK)
Surface epitheliopathy2,7

Stage 2

Persistent epithelial
defect (PED)2

Stage 3

Corneal ulcer2

NK is a progressive disease and can present at any stage—early diagnosis is essential2,4,6

* Based on the Mackie classification.2

Images show neurotrophic corneal lesions in 3 different patients and do not represent 1 patient’s disease progression.

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Diagnosis

When NK is suspected, confirm
with corneal sensitivity testing1

Early diagnosis is critical as progression of NK can often be asymptomatic.2,4,6

Consider corneal sensitivity testing as part of a broader diagnostic workup, including6:

  • Patient medical history
  • Microbiological exam
  • Fluorescein staining
  • Evaluation for systemic conditions

Important: Do not numb the eye when performing staining. Numbing will obscure results of corneal sensitivity testing.8

Watch the video to hear from Dr Francis Mah on how he performs corneal sensitivity testing

How to perform corneal sensitivity testing2,6

  • Qualitative testing: cotton wisp or dental floss
  • Quantitative testing: Cochet-Bonnet esthesiometer
  • Test all 4 quadrants and the center of the cornea
  • Record sensation as normal, reduced, or absent using the healthy eye as reference

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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. 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. 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. 2. Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018;66:107-131. 3. Labetoulle M, Baudouin C, Calonge M, et al. Role of corneal nerves in ocular surface homeostasis and disease. Acta Ophthalmol. 2019;97:137-145. 4. Saad S, Abdelmassih Y, Saad R, et al. Neurotrophic keratitis: frequency, etiologies, clinical management and outcomes. Ocul Surf. 2020;18:231-236. 5. Roth M, Dierse S, Alder J, Holtmann C, Geerling G. Incidence, prevalence, and outcome of moderate to severe neurotrophic keratopathy in a German tertiary referral center from 2013 to 2017. Graefes Arch Clin Exp Ophthalmol. 2022;260:1961-1973. 6. Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014;8:571-579. 7. Versura P, Giannaccare G, Pellegrini M, Sebastiani S, Campos EC. Neurotrophic keratitis: current challenges and future prospects. Eye Brain. 2018;10:37-45. 8. NaPier E, Camacho M, McDevitt TF, Sweeney AR. Neurotrophic keratopathy: current challenges and future prospects. Ann Med. 2022;54:666-673.