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

Prescribing Information

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

In clinical trials, up to 72% of patients achieved complete corneal healing at week 8 with a single course of therapy.*†1-3

Of the patients in the REPARO (Study NGF0212) trial who achieved complete corneal healing, 80% remained completely healed at 1 year.*4

*

Resolution was evaluated in clinical trials as complete corneal healing, 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.1-3

Key study findings were after 8 weeks of treatment, 6 times daily. REPARO (Study NGF0212): 52 patients with Stage 2 or 3 neurotrophic keratitis (NK) in 1 eye per group; 72% (36/50) of patients completely healed; vehicle response rate 33.3% (17/51). Study NGF0214: 24 patients with Stage 2 or 3 NK in 1 or both eyes per group; 65.2% (15/23) completely healed; vehicle response rate 16.7% (4/24). Last post-baseline observation carried forward; chi-squared test. Patients without any post-baseline measurements were excluded from the analysis.1-3

Up to 72% of OXERVATE®-treated patients achieved complete corneal healing*1-3

REPARO (Study NGF0212)†2

OXERVATE‡ 20 mcg/mL (n=50)

Vehicle (n=51)

Study NGF02143

OXERVATE 20 mcg/mL (n=23)

Vehicle (n=24)

§ Last post-baseline observation carried forward; chi-squared test. Patients without any post-baseline measurements were excluded from the analysis.

*

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.1-3

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.

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*1-3

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.

Baseline

Stage 2 NK
History of herpes zoster and diabetes

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.1-3

Get information on real-world patients treated with OXERVATE

Safety Profile

OXERVATE® was generally well tolerated in clinical trials2,3

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. 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

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. 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]. Boston, MA; Dompé U.S. Inc.; 2023. 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. Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018;66:107-131.

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]. Boston, MA; Dompé U.S. Inc.; 2023. 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. Dua HS, Said DG, Messmer EM, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018;66:107-131.

This site is intended for US healthcare professionals only.
© 2024 Dompé U.S. Inc. All rights reserved.
US-OXE-2200064.1   03/24

This site is intended for US healthcare professionals only.
© 2024 Dompé U.S. Inc. All rights reserved.
US-OXE-2200064.1   03/24