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

Prescribing Information

Dosing & Administration

Clinical trial results based on an 8-week course of treatment.1

Dosing

A full 8-week treatment with OXERVATE was shown to provide complete corneal healing in many patients with NK*1

Recommended dosage and dose administration1

Instill 1 drop
in the affected eye(s),
6 times daily

At 2-hour
intervals

For
8 weeks

One drop of OXERVATE in the affected eye(s),
6 times per day at 2-hour intervals, for 8 weeks1

*

The efficacy and safety of OXERVATE for the treatment of neurotrophic keratitis was studied in a total of 151 patients, evaluated in two 8-week, randomized, multi-center, double-masked, vehicle-controlled studies. In NGF0214, the percentage of patients with complete corneal healing at week 8 was 65.2% (15/23) in the OXERVATE arm vs 16.7% (4/24) in the vehicle arm with a treatment difference of 48.6% (95% CI: 24%, 73.1%; P<0.01). In NGF0212, the percentage of patients with complete corneal healing at week 8 was 72% (36/50) in the OXERVATE arm vs 33.3% (17/51) in the vehicle arm with a treatment difference of 38.7% (95% CI: 20.7%, 56.6%; P<0.01). Patients without any post-baseline measurements were excluded from the analysis.1

In clinical trials, complete corneal healing was defined as absence of staining of the corneal lesion and no persistent staining in the rest of the cornea at 8 weeks of treatment.1

Administration

The active ingredient in OXERVATE® is a recombinant human nerve growth factor (rhNGF)1

General dosing information1

  • Contact lenses should be removed before applying OXERVATE and may be reinserted 15 minutes after administration.
  • If a dose is missed, treatment should be continued as normal at the next scheduled administration.
  • If more than 1 topical ophthalmic product is being used, administer the eye drops at least 15 minutes apart to avoid diluting products. Administer OXERVATE 15 minutes prior to using any eye ointment, gel, or other viscous eye drops.

Instill one drop of OXERVATE in the affected eye(s), 6 times a day at 2-hour intervals for 8 weeks.

Remove the weekly carton(s) containing OXERVATE vials from the insulated pack and store it for up to 14 days in a refrigerator (no later than 5 hours from when you receive the medicine from your pharmacy). OXERVATE is stored in a freezer at the pharmacy. If treatment is started immediately after receiving the weekly carton, wait until the first vial is thawed (this could take up to 30 minutes when kept at room temperature up to 77 °F (25 °C)). Do not shake the vial.

Watch a demo on how to administer OXERVATE

OXERVATE is supplied in an insulated pack, in weekly cartons containing 7 multiple-dose vials.1 This may include either frozen and/or refrigerated gel packs or, in some cases, dry ice.2

The OXERVATE Kit

OXERVATE is supplied in weekly cartons containing 7 multiple-dose vials1

OXERVATE is dispensed to patients in an insulated pack and co-packaged with the Delivery System Kit. The Delivery System Kit contains1:

7 vial adapters for the week
+ 1 extra adapter

42 pipettes for the week
+ 3 extra pipettes

42 sterile disinfectant wipes for the week + 3 extra wipes

1 Dose Recording Card

Storage

The OXERVATE carton should be stored in the refrigerator1

Patients should refrigerate OXERVATE as soon as possible after receiving it1

OXERVATE is supplied in an insulated pack, in weekly cartons containing 7 multiple-dose vials.1 This may include either frozen and/or refrigerated gel packs or, in some cases, dry ice.2

Pharmacy Storage1

Store the weekly cartons containing OXERVATE vials in the freezer at or below -4 ºF (-20 ºC). Dispense the weekly carton(s) containing OXERVATE vials in an insulated pack in combination with the Delivery System Kit.

Storage of weekly cartons:
Within 5 hours of delivery, store the weekly carton(s) containing OXERVATE vials in the refrigerator between 36 °F and 46 °F (2 °C to 8 °C) for up to 14 days.1
Storage of opened vials:
A vial opened for daily use may be stored in the original weekly carton in the refrigerator between 36 °F and 46 °F (2 °C to 8 °C) or at room temperature up to 77 °F (25 °C), for up to 12 hours.1
  • Do not refreeze the vials1
  • Do not shake the vials1
  • Discard the opened vial after 12 hours even if there is still some solution left inside1

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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.

References: 1. OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) [US package insert]. San Mateo, CA: Dompé U.S. Inc.; 2024. 2. Data on File. Accredo® Oxervate Cold Chain Pack Out Performance and Mechanical Testing Expanded Polystyrene Shipping Containers. Dompé U.S. Inc.; 2024.