OXERVATE® is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis (NK).

Prescribing Information

THE FIRST AND ONLY FDA-APPROVED TREATMENT OPTION

FOR PATIENTS WITH NEUROTROPHIC KERATITIS1,2

The largest combined clinical trial program
in patients with NK3,4
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An 8-week
course of therapy1
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About NK

NK may be caused by corneal nerve damage5

Corneal nerve damage may lead to a decrease in or total loss of corneal sensitivity—a hallmark of neurotrophic keratitis (NK).6

This impairment in corneal innervation and sensitivity may then lead to epithelial breakdown in the cornea.6

When to suspect NK

 

The image is for illustrative purposes only.

MECHANISM OF ACTION (MOA)

The active ingredient in OXERVATE is a recombinant human nerve growth factor (rhNGF)1

Nerve growth factor (NGF) is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (ie, TrkA) and low-affinity (ie, p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.1

MECHANISM OF ACTION

Efficacy & Safety

The efficacy and safety of OXERVATE for the treatment of NK were studied in a total of 151 patients, evaluated in two 8-week, randomized, multi-center, double-masked,
vehicle-controlled studies1

Patients received study treatment dosed 6 times daily in the affected eye(s) for 8 weeks.1

Two bar charts showing corneal healing rates with OXERVATE vs vehicle control

Week 8

Study NGF0212 (REPARO)3

Week 8

Study NGF0214

*

In clinical trials complete corneal healing was defined as absence of staining of the corneal lesion and no persistent staining in the rest of the cornea at 8 weeks of treatment.1

†

Patients without any post-baseline measurements were excluded from the analysis.1

In patients who were healed after 8 weeks of treatment with OXERVATE, recurrences occurred in ~20% of patients in Study NGF0212 and 14% of patients in Study NGF0214.1

OXERVATE safety in clinical trials1

The most common adverse reaction was eye pain following instillation, which was reported in approximately 16% of patients.1

Eye pain may arise as corneal healing occurs.1

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.1

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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. FDA approves first drug for neurotrophic keratitis, a rare eye disease. U.S. Food and Drug Administration; August 22, 2018. Accessed December 3, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-neurotrophic-keratitis-rare-eye-disease 3. Bonini S, Lambiase A, Rama P, et al. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125:1332-1343. 4. Pflugfelder SC, Massaro-Giordano M, Perez VL, et al. Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multi-center randomized vehicle-controlled pivotal trial. Ophthalmology. 2020;127:14-26. 5. 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. 6. Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018;66:107-131.