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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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NOT JUST ANY SOLUTION

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OXERVATE® is the only FDA-approved treatment option that targets the underlying cause of NK to enable complete corneal healing in most patients.*1-6

The most common adverse reaction reported in clinical trials (~16%) was eye pain following instillation.1

*

Resolution was evaluated in clinical trials as complete corneal healing, defined as the absence of staining in the lesion area and no persistent staining in the rest of the cornea after 8 weeks of treatment and as <0.5-mm lesion staining at 48-week follow-up.1,4,5

The largest clinical trial program
for patients with NK1
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One 8-week
course of therapy1
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When to suspect NK BG texture
About NK

NK is caused by corneal nerve damage6

Corneal nerve damage may lead to a decrease in or total loss of corneal sensitivity—the hallmark of neurotrophic keratitis (NK).7

NK is a progressive condition and is classified into 3 stages of increasing severity (based on the Mackie classification). If left untreated, NK can lead to severe corneal damage.2,7

When to suspect NK
how ngf works bg Close-up of the nerves at the bottom of the drop of liquid
OXERVATE MOA

A unique mechanism of action that targets corneal nerve damage, the underlying cause of NK1-3,6

Cenegermin-bkbj, the active ingredient in OXERVATE, is a recombinant form of human nerve growth factor (NGF) that supports corneal innervation and integrity.1-3,6,7

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Efficacy & Safety

The efficacy and safety of OXERVATE® were established in the largest clinical trial program conducted in patients with NK1

In clinical trials, up to

72%

of patients achieved complete corneal healing at week 8
with a single course of therapy*†1

Of these patients, (REPARO trial)

80%

remained
completely healed
at 1 year†8

*

Key study findings were after 8 weeks of treatment, 6 times daily. REPARO (Study NGF0212): 52 European patients with neurotrophic keratitis (NK) in 1 eye per group; 72% of patients completely healed; vehicle response rate 33.3%. Study NGF0214: 24 US patients with NK in 1 or both eyes per group; 65.2% completely healed; vehicle response rate 16.7%.4,5

†

Complete corneal healing was defined as the absence of staining in the lesion area and no persistent staining in the rest of the cornea after 8 weeks of treatment and as <0.5-mm lesion staining at 48-week follow-up.4,5

In clinical trials, OXERVATE was generally well tolerated1

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

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

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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. 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. 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. 5. Pflugfelder SC, Massaro-Giordano M, Perez VL, et al. Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multicenter randomized vehicle-controlled pivotal trial. Ophthalmology. 2020;127:14-26. 6. 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. 7. Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014;8:571-579. 8. Data on File. Clinical Study Report (NGF0212). Dompé U.S. Inc, 2016.