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

Prescribing Information
OXERVATE® (cenegermin-bkbj ophthalmic solution) 0.002% (20 mcg/mL) Resolutionary Care logo
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Efficacy & Safety

The efficacy and safety of OXERVATE® were established in the largest clinical trial program conducted in patients with neurotrophic keratitis (NK)1

Efficacy

Complete and long-lasting resolution for most patients*1-4

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In clinical trials, up to 72% of patients achieved complete corneal healing at week 8 with a single course of therapy.*†1

Of the patients in the REPARO trial who achieved complete corneal healing, 80% remained completely healed at 1 year.*4

*

Complete corneal healing was defined as the absence of staining in the lesion area and no persistent staining in the rest of the cornea after 8 weeks of treatment and as <0.5-mm lesion staining at 48-week follow-up.2,3

†

Key study findings were after 8 weeks of treatment, 6 times daily. REPARO (Study NGF0212): 52 European patients with neurotrophic keratitis (NK) in 1 eye per group; 72% of patients completely healed; vehicle response rate 33.3%. Study NGF0214: 24 US patients with NK in 1 or both eyes per group; 65.2% completely healed; vehicle response rate 16.7%.2,3

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Up to 72% of OXERVATE®-treated patients achieved complete corneal healing*1

A bar graph representing the results of OXERVATE® treatment at 8 weeks compared to vehicle in 2 clinical trials

REPARO (Study NGF0212)†

OXERVATE‡ 20 mcg/mL (n=52)

Vehicle (n=52)

A bar graph representing the results of OXERVATE® treatment at 8 weeks compared to vehicle in 2 clinical trials

Study NGF0214

OXERVATE 20 mcg/mL (n=24)

Vehicle (n=24)

*

Complete corneal healing was defined as the absence of staining in the lesion area and no persistent staining in the rest of the cornea after 8 weeks of treatment.2,3

†

In REPARO, complete corneal healing (defined as <0.5-mm lesion staining) at 8 weeks was evaluated as a prespecified secondary endpoint. Additionally, as a post hoc efficacy analysis, corneal healing was reassessed more conservatively by masked central readers and was defined as 0-mm lesion staining and no other persistent staining outside of the lesion.2

‡

The formulation that was tested in REPARO did not include the antioxidant methionine and is not the final formulation that is marketed as OXERVATE®. Methionine is an excipient added to the commercial formulation to improve its stability. More than 1 study was conducted with the final commercial formulation. No difference in safety was seen in either of the trials.

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Study Design

Two independent, 8-week, randomized, multicenter, double-masked, vehicle-controlled clinical trials1-3

REPARO (STUDY NGF0212) (EUROPE, N=156)*2

STUDY NGF0214 (UNITED STATES, N=48)*3

Clinical Outcomes

Most patients experienced complete healing of the corneal surface*1,2,4

Images show a neurotrophic corneal lesion from baseline to week 8 in an actual patient treated with OXERVATE® in the REPARO (Study NGF0212) trial. Results are not indicative of all patients.

Fluorescein staining of an eye with Stage 2 (moderate) neurotrophic keratitis (NK) at baseline, as seen under cobalt blue light

Baseline

Stage 2 NK
History of herpes zoster and diabetes

Fluorescein staining of the same eye showing treatment results at week 8, as seen under cobalt blue light

Week 8

Complete corneal healing*

*

Complete corneal healing was defined as the absence of staining of the lesion area and no persistent staining in the rest of the cornea after 8 weeks of treatment.2,3

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Safety Profile

OXERVATE® was generally well tolerated in clinical trials1

Contact lenses should be removed before applying OXERVATE1

  • 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 treatment1

  • Advise patients to contact their doctor if a more serious eye reaction occurs
  • In clinical trials, the most common adverse reaction was eye pain following instillation, which was reported in approximately 16% of patients
  • Other adverse reactions occurring in 1%-10% of OXERVATE patients, and more frequently than in the vehicle-treated patients, included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, and tearing

Most adverse events were local, mild, transient, and did not require treatment discontinuation2,3

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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. Other adverse reactions occurring in 1% to 10% of OXERVATE patients and more frequently than in the vehicle-treated patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation and tearing.

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]. Boston, MA; Dompé U.S. Inc.; 2019. 2. Bonini S, Lambiase A, Rama P, et al. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125:1332-1343. 3. Pflugfelder SC, Massaro-Giordano M, Perez VL, et al. Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multicenter randomized vehicle-controlled pivotal trial. Ophthalmology. 2020;127:14-26. 4. Data on File. Clinical Study Report (NGF0212). Dompé U.S. Inc, 2016. 5. Mastropasqua L, Lanzini M, Dua HS, et al. In vivo evaluation of corneal nerves and epithelial healing after treatment with recombinant nerve growth factor for neurotrophic keratopathy. Am J Ophthalmol. 2020;217:278-286.