For the treatment of all stages of neurotrophic keratitis (NK)

Prescribing Information

For eye care professionals

Featured Resource

NK Diagnosis and Staging Tool

Overview of common etiologies, signs and symptoms, and tests of NK

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OXERVATE® Prescribing Information

Prescribing Information, Instructions for Use, and Patient Information

OXERVATE Overview

An overview of NK and OXERVATE

HCP DC2C Overview

List of access program resources

Featured Resource

DC2C Enrollment Form

OXERVATE prescription form and patient enrollment

iAssist One Pager

An overview on enrolling patients through the iAssist digital portal

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OXERVATE Administration

Instructional video for dosing and administration

Performing Corneal Sensitivity Testing With a Cotton Wisp

Dr Francis Mah discusses how he tests for corneal sensitivity using a cotton wisp

Mechanism of Action (MOA) of OXERVATE

Animated explanation of how the active ingredient works

For office staff

OXERVATE Overview

An overview of NK and OXERVATE

Featured Resource

NK Diagnosis and Staging Tool

Overview of common etiologies, signs and symptoms, and tests of NK

Featured Resource

DC2C Enrollment Form

OXERVATE prescription form and patient enrollment

Featured Resource

Appeal Letter Guide

Insurance appeals overview and sample letter

Featured Resource

HCP DC2C Roadmap

HCP process for the access program

HCP DC2C Overview

List of access program resources

iAssist One Pager

An overview on enrolling patients through the iAssist digital portal

Featured Resource

OXERVATE Administration

Instructional video for dosing and administration

For patients

Featured Resource

OXERVATE Patient Brochure

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

OXERVATE Patient Website

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

Featured Resource

OXERVATE Patient Quickstart Guide

Administrative overview post‑prescription of OXERVATE

Patient DC2C Roadmap

Patient-friendly instructions for the access program

Featured Resource

OXERVATE Administration

Instructional video for dosing and administration

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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.