Neurotrophic keratitis is a disease that affects the health of the cornea2

Neurotrophic

(NOOR-uh-TROF-ik)

means relating to the nutrition and health of the nerves

Keratitis3

(KER-uh-TITE-us)

means inflammation of the cornea

Neurotrophic keratitis is also sometimes called neurotrophic keratopathy. It's a disease caused by damage to the corneal nerves and affects fewer than 65,000 persons in the United States.2

If untreated, moderate neurotrophic keratitis can worsen and become severe with risks of ulcers and scarring on the cornea, which could lead to vision loss.4,6

Think of your cornea as a shield for your eye

Your cornea contains roughly 7,000 nerve endings per square millimeter.5,6 These nerves are essential to the health of your eyes because they help with reflexes such as blinking and tearing. This helps your eye maintain a healthy surface.4

The cornea:

  • Covers your pupil and iris4,10

  • Helps protect your eye from bacteria and dust4,10

  • Controls how much light enters your eye, which helps to focus your vision4,10

There are many risk factors that cause neurotrophic keratitis2,4,6,7,11

Unlike most tissues in your body, the cornea doesn’t have blood vessels. Instead, corneal nerves provide both protection and nourishment.4

Damage to these nerves leads to the development of neurotrophic keratitis and can have many causes.2,4,6,7,11

Not everyone has the same signs and symptoms of neurotrophic keratitis

Symptoms of neurotrophic keratitis may include changes in tear viscosity, redness in the eyes, and blurred vision.2,8

Some people with neurotrophic keratitis may not even feel the symptoms because their damaged corneal nerves no longer feel sensation.2,4

Getting the correct diagnosis is key to getting the right treatment!

OXERVATE is the first FDA-approved prescription eye drop that is for neurotrophic keratitis.1

Learn more about OXERVATE and what types of questions to ask your doctor.

About 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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