Ask your doctor if 8 weeks of OXERVATE will make a difference with your neurotrophic keratitis

What is OXERVATE?

OXERVATE is the first FDA-approved treatment for people with neurotrophic keratitis. The main ingredient of OXERVATE is cenegermin, a recombinant form of human nerve growth factor. OXERVATE is structurally identical to the nerve growth factor that is naturally produced by your eyes.1,6

Nerve growth factor, made in the body, works to help corneal cells survive2,4,5

Nerve growth factor is thought to be involved in the maintenance of nerves that support corneal health.1,6

In your eyes, naturally ocurring nerve growth factor is thought to:2

  • Foster healing of the cells on corneal surface
  • Help promote tear secretion
  • Help improve the function of the nerves in the cornea

Scientific studies have also shown that nerve growth factor helps corneal epithelial cells and corneal nerves survive.4,5,9

These results were achieved by patients who took the full 8 weeks of OXERVATE therapy in the REPARO clinical trial1

Up to 72% of patients taking OXERVATE in clinical trials* had complete corneal healing
Approximately 80% of patients remained completely healed 1 year after completing OXERVATE therapy
OXERVATE was studied in the largest clinical trial program of patients with neurotrophic keratitis1

*Study NGF0212 (REPARO): N=52 per group; European patients with neurotrophic keratitis in one eye; key findings were after 8 weeks of treatment; 6 times daily; vehicle response rate: 33.3%.1,6
Study NGF0214: N=24 per group; U.S. patients with neurotrophic keratitis in one or both eyes; 65.2% completely healed; vehicle response rate: 16.7%.1,6

In clinical trials, up to 72% of patients achieved complete corneal healing, defined as the absence of staining of the corneal lesion and no persistent staining in the rest of the cornea after 8 weeks of OXERVATE treatment.1,6

OXERVATE is safe and well tolerated in patients 2 years of age and older1,‡

Most side effects were mild and temporary. Eye pain was the most common side effect, experienced by 16% of people taking OXERVATE in clinical trials.

Other less common side effects included:

  • Feeling of having something in the eye
  • Redness in the whites of the eye
  • Swelling (inflammation) of the eye
  • Increase in tears
  • Corneal deposits

If you wear contact lenses, please remove them before applying OXERVATE and wait 15 minutes after you apply the drops to reinsert your lenses.

The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in this population is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in pediatric patients from 2 years of age and older.

When taking OXERVATE think 2-6-8!

Apply 1 drop of OXERVATE to the affected eye(s):

  • Every 2 hours
  • 6 times a day (within a 12-hour period)
  • For 8 weeks
Access OXERVATE
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References:

  1. OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) [US package insert]. Boston, MA: Dompé U.S. Inc.; 2018.
  2. Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis [Internet]. Clin Ophthalm. 2014 Mar;8:571-579.
  3. Stedman's Medical Dictionary. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
  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 Apr;232(4):717-724.
  5. Müller LJ, Marfurt CF, Kruse F, et al. Corneal nerves: structure, contents and function [Internet]. Exp Eye Res. 2003 May;76(5):521-542.
  6. Bonini S, Rama P, Olzi D, et al. Neurotrophic keratitis [Internet]. Eye. 2003 Nov;17:989-995.
  7. Versura P, Giannaccare G, Pellegrini M, Sebastiani S, Campos E. Neurotrophic keratitis: current challenges and future prospects. Eye Brain. 2018; 10:37-45.
  8. Feroze KB, Patel BC. Neurotrophic Keratitis. [Updated 2019 Jan 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2019 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK431106/.
  9. Lambiase A, Sacchetti M. Neurotrophic factors and corneal nerve regeneration. Neural Regen Res. 2017;12(8):1220.
  10. Facts About the Cornea and Corneal Disease | National Eye Institute. https://nei.nih.gov/health/cornealdisease. Published 2016. Accessed June 5, 2019.
  11. Dua H, Said D, Messmer E, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018;66:107-131.

Important Safety Information

OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

Important Safety Information

MORE LESS

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.

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.

The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Adverse reactions included corneal deposits, foreign body sensations in the eye, ocular hyperemia (enlarged blood vessels in the white of the eyes), swelling (inflammation) of the eye, and increase of tears (1-10% of patients).

WHAT IS OXERVATE™?

OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

DOSAGE FORMS AND STRENGTHS

Ophthalmic solution for topical use in the eye: cenegermin-bkbj 0.002% (20 mcg/mL) is a clear, colorless solution in a multiple-dose vial.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Use With Contact Lenses

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

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be compared directly to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In 2 clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95).

The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase in tears (1%-10% of patients).

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

There are no data from the use of OXERVATE in pregnant women to inform any drug-associated risks.

Administration of cenegermin-bkbj to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses. In a pre- and postnatal development study, administration of cenegermin-bkbj to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses.

Data

Animal Data

In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in postimplantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the maximum recommended human ophthalmic dose [MRHOD]). A no-observed-adverse-effect level (NOAEL) was not established for postimplantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed once each in fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart, and aortic arch dilation, were observed once each in fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

In a pre- and postnatal development study, daily subcutaneous administration of cenegermin-bkbj to pregnant rats during the period of organogenesis and lactation did not affect parturition and was not associated with adverse toxicity in offspring at doses up to 267 mcg/kg/day.

In parental rats and rabbits, an immunogenic response to cenegermin-bkbj was observed. Given that cenegermin-bkbj is a heterologous protein in animals, this response may not be relevant to humans.

Lactation

Risk Summary

There are no data on the presence of OXERVATE in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OXERVATE and with any potential adverse effects on the breastfed infant.

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.

Geriatric Use

Of the total number of subjects in clinical studies of OXERVATE, 43.5% were 65 years old and older. No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

The risk information provided here is not comprehensive. To learn more, talk about OXERVATE with your health care provider or pharmacist.

Important Safety Information

MORE LESS

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.

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.

The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Adverse reactions included corneal deposits, foreign body sensations in the eye, ocular hyperemia (enlarged blood vessels in the white of the eyes), swelling (inflammation) of the eye, and increase of tears (1-10% of patients).

WHAT IS OXERVATE™?

OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

DOSAGE FORMS AND STRENGTHS

Ophthalmic solution for topical use in the eye: cenegermin-bkbj 0.002% (20 mcg/mL) is a clear, colorless solution in a multiple-dose vial.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Use With Contact Lenses

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

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be compared directly to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In 2 clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95).

The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase in tears (1%-10% of patients).

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

There are no data from the use of OXERVATE in pregnant women to inform any drug-associated risks.

Administration of cenegermin-bkbj to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses. In a pre- and postnatal development study, administration of cenegermin-bkbj to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses.

Data

Animal Data

In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in postimplantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the maximum recommended human ophthalmic dose [MRHOD]). A no-observed-adverse-effect level (NOAEL) was not established for postimplantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed once each in fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart, and aortic arch dilation, were observed once each in fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

In a pre- and postnatal development study, daily subcutaneous administration of cenegermin-bkbj to pregnant rats during the period of organogenesis and lactation did not affect parturition and was not associated with adverse toxicity in offspring at doses up to 267 mcg/kg/day.

In parental rats and rabbits, an immunogenic response to cenegermin-bkbj was observed. Given that cenegermin-bkbj is a heterologous protein in animals, this response may not be relevant to humans.

Lactation

Risk Summary

There are no data on the presence of OXERVATE in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OXERVATE and with any potential adverse effects on the breastfed infant.

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.

Geriatric Use

Of the total number of subjects in clinical studies of OXERVATE, 43.5% were 65 years old and older. No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

The risk information provided here is not comprehensive. To learn more, talk about OXERVATE with your health care provider or pharmacist.

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