OXERVATE® is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis (NK).

Prescribing Information

Resources

For eye care professionals

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OXERVATE® (cenegermin-bkbj) Prescribing Information

Prescribing Information, Instructions for Use, and Patient Information

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Patient Enrollment Form

OXERVATE prescription and patient enrollment form

Patient Authorization Form

Patient consent form to be used when e-prescribing

Spanish Patient Authorization Form

Patient consent form to be used when e-prescribing

Letter of Medical Necessity

Sample document to provide practices with guidance when submitting their patient prior authorizations

Appeal Letter Guide

Sample appeal letter used to provide guidance on the OXERVATE appeal process

OXERVATE ECP Access Roadmap

An overview of the steps from prescription to first shipment

Dompé Suite of Services

An overview of the different services and support teams involved in the OXERVATE access process

CoAssist Pharmacy Guide

A simple, step-by-step guide to e-prescribing to CoAssist Pharmacy

Affordability & Access Guide

An overview of the financial assistance options available to your patients

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OXERVATE (cenegermin-bkbj) Administration

Instructional video for dosing and administration

Spanish OXERVATE (cenegermin-bkbj) Administration

Instructional video for dosing and administration

For patients

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OXERVATE (cenegermin-bkbj) Patient Brochure

Patient-friendly overview of NK, OXERVATE, and the access process

OXERVATE (cenegermin-bkbj) Patient Website

Detailed look at NK, how to use OXERVATE, how OXERVATE works, and Important Safety Information for OXERVATE

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OXERVATE (cenegermin-bkbj) Patient Quickstart Guide

Administrative overview post‑prescription of OXERVATE

Patient DC2C Roadmap

Patient-friendly instructions for the access program

Featured Resource

OXERVATE (cenegermin-bkbj) Administration

Instructional video for dosing and administration

Spanish OXERVATE (cenegermin-bkbj) Administration

Instructional video for dosing and administration

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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.