OXERVATE is the only prescription eye drop that is FDA approved to treat neurotrophic keratitis1,6

How do I get OXERVATE?

OXERVATE is a prescription medication and you will need to speak with your doctor to determine if it is right for you. If you are prescribed OXERVATE, the Dompé Connect to Care program is here to help you access the medication.

Dompé partners with Accredo, a specialty pharmacy, to support the Connect to Care program. Accredo will work with you to receive OXERVATE.

Learn how to dose and administer OXERVATE properly

Please watch this video and read the complete instructions for OXERVATE administration supplied with the kit.

Watch demo video

Dompé is committed to patient support

Dompé provides resources to support patients through the process of accessing OXERVATE. The Dompé Connect to Care Program will:

Verify a patient's health insurance coverage for OXERVATE
Determine a patient's eligibility for financial assistance and may help with costs not covered by insurance
Coordinate delivery of OXERVATE to the patient and provide resources about how to administer OXERVATE

Calling 1-877-831-8112 puts you in contact with Patient Care Advocates, as well as licensed Pharmacists and Nurses at Accredo who are ready to help answer questions about your prescription and OXERVATE.

How OXERVATE is delivered

You must speak to your Connect to Care representative live in order to receive your first shipment
Shipments can be delivered anywhere in the United States, as long as you are there to receive them
OXERVATE is delivered in an insulated pack with dry ice. Use gloves when opening to protect your hands

OXERVATE is supplied in a weekly carton containing 7 multiple-dose vials in a cooler with an accompanying Delivery System Kit. For weekly use you will receive:

7 vials of OXERVATE 20 mcg/mL
1 vial to be used per day of the week (in an insulated pack)
7 vial adapters
42 pipettes
42 sterile
disinfectant wipes
1 dose recording card

1 extra adapter, 3 extra pipettes, and 3 extra wipes are included as spares

When taking OXERVATE,
think: 2, 6, 8!

  • Apply 1 drop of OXERVATE, every 2 hours to your affected eye(s) 6 times per day (in a 12-hour period) for 8 weeks
  • One vial of OXERVATE per affected eye is to be used each day
  • Follow the rule of 15: 15 minutes before and after applying OXERVATE
    • Contact lenses should be removed before applying OXERVATE and may be reinserted 15 minutes after administration
    • If more than one topical ophthalmic product is being used, apply the eye drops at least 15 minutes apart to avoid dilution
    • Administer OXERVATE 15 minutes prior to using any eye ointment, gel, or other viscous eye drops
Every 2 hours
6 times daily
For 8 weeks

Learn about OXERVATE storage

  • Refrigerate OXERVATE as soon as possible after receiving it
  • Once refrigerated, it can be stored up to 14 days in the original carton if the vials are unopened
  • If you need to use OXERVATE right away, let the vial sit at room temperature for 30 minutes until the vial is thawed
  • A vial of OXERVATE can remain at room temperature for up to 12 hours once it is opened
  • Once a vial of OXERVATE is opened, it must be discarded within 12 hours (even if solution is left in the vial)

Talk to your doctor:

  • Before using other eye medicines with OXERVATE
  • Before you decide to stop taking OXERVATE
  • If you have any questions about how to use 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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