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

Prescribing Information

NOT JUST ANY SOLUTION

OXERVATE® is the only FDA-approved treatment option to enable complete corneal healing in most patients with NK.*1-3

OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment.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.1-3

The largest clinical trial program
for patients with NK1
One 8-week
course of therapy1
Access support through a
single point of contact
About NK

NK is caused by corneal nerve damage4

Corneal nerve damage may lead to a decrease in or total loss of corneal sensitivity—the hallmark of neurotrophic keratitis (NK).5

This impairment in corneal innervation and sensitivity can then lead to epithelial breakdown in the cornea.5

OXERVATE MOA

A unique mechanism of action that targets corneal nerve damage, the underlying cause of NK1,4,6,7

Cenegermin-bkbj, the active ingredient in OXERVATE, is a recombinant form of human nerve growth factor (rhNGF).1

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

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*†1-3

Of these patients in REPARO (Study NGF0212),

80%

remained
completely healed
at 1 year*8

*

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.1-3

Key study findings were after 8 weeks of treatment, 6 times daily. REPARO (Study NGF0212): 52 patients with Stage 2 or 3 neurotrophic keratitis (NK) in 1 eye per group; 72% (36/50) of patients completely healed; vehicle response rate 33.3% (17/51). Study NGF0214: 24 patients with Stage 2 or 3 NK in 1 or both eyes per group; 65.2% (15/23) completely healed; vehicle response rate 16.7% (4/24). Last post-baseline observation carried forward; chi-squared test. Patients without any post-baseline measurements were excluded from the analysis.1-3

In clinical trials, OXERVATE was generally well tolerated2,3

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.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

Access support and more through a single point of contact

Dompé CONNECT to Care provides practices and patients with assistance every step of the way.

Sign up for additional
resources and to
stay up to date
about OXERVATE

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. OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (‍20 mcg/mL) [US package insert]. Boston, MA; Dompé U.S. Inc.; 2023. 2. 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. 3. 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. 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. Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018;66:107-131. 6. Lambiase A, Sacchetti M, Bonini S. Nerve growth factor therapy for corneal disease. Curr Opin Ophthalmol. 2012 Jul;23(4):296-302. 7. Ruiz-Lozano RE, Hernandez-Camarena JC, Loya-Garcia D, Merayo-Lloves J, Rodriguez-Garcia A. The molecular basis of neurotrophic keratopathy: Diagnostic and therapeutic implications. A review. Ocul Surf. 2021 Jan;19:224-240. 8. Data on File. Clinical Study Report (NGF0212). Dompé U.S. Inc., 2016.