Resource Portal

Clinical Resources

All Clinical Resources

Oxervate USPI

Prescribing Information, Instructions for Use, and Patient Information

Download PDF

OXERVATE Patient Case Supplement

Expert roundtable supplement covering real world Oxervate patient cases

Download PDF

OXERVATE & Neurotrophic Keratitis Fact Sheet

High-level overview of OXERVATE and NK

Download PDF
All Clinical Resources

Access Resources – Dompé CONNECT to Care (DC2C)

All Access Resources

DC2C Enrollment Form

OXERVATE prescription form and patient enrollment

Download PDF

Appeal Letter Guide

Insurance appeals overview and sample letter

Download PDF

HCP DC2C Roadmap

HCP process for the access program

Download PDF

HCP DC2C Overview

List of access program resources

Download PDF
All Access Resources

Patient Resources

All Patient Resources

Oxervate Administration Video

Instructional video for dosing and administration

Watch Video

Oxervate Patient Brochure

Patient friendly overview about NK, OXERVATE, and access process

Download PDF

DC2C Patient Roadmap

Patient-friendly instructions for the access program

Download PDF
All Patient Resources

Video Resources

All Video Resources

OXERVATE Administration Video

Instructional video for dosing and administration

Watch Video

How Oxervate targets NK

Drs. Salinger and Lee discuss the MOA of Oxervate

Watch Video

Oxervate Clinical Trial Results

Drs. Salinger and Lee discuss the efficacy and safety of Oxervate

Watch Video

Patient Selection for Oxervate

Drs. Salinger and Lee discuss patient types for Oxervate

Watch Video

Practical Considerations for Oxervate

Drs. Salinger and Lee discuss their lessons learned utilizing Oxervate in their practices

Watch Video
All Video Resources

Important Safety Information

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 sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase of tears (1-10% of patients).

INDICATION
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 FDA-approved product labeling can be found here. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Dompé at 1-833-366-7387 or Usmedinfo@dompe.com.

© 2020 Dompé U.S. All rights reserved.
US-OXE-2000069 04/20

Contact Rep

Please fill out the form below and a Dompe’ representative will get in touch with you.

Are you a healthcare professional?

The information contained on this healthcare professionals’ site is intended for US physicians only.