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

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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For US healthcare professionals only.

Important Safety Information

WARNINGS AND PRECAUTIONS

Contact lenses, either therapeutic or corrective, should be removed before applying OXERVATE. Contact lenses may be reinserted 15 minutes after OXERVATE administration.

Eye Discomfort, such as eye pain, that can be mild to moderate can occur with OXERVATE. Patients should contact their health care provider if a more serious eye reaction occurs.

ADVERSE REACTIONS

The most common adverse reaction with OXERVATE (~16%) was eye pain. Other adverse reactions with OXERVATE (1% to 10%) included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache.

Please read the 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.