Important Safety Information Prescribing Information
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OXERVATE® (cenegermin-bkbj)
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EFFICACY & SAFETY

Up to 72% of Patients Reported
Complete Corneal Healing After a
Single 8-week Course of Treatment1,*

Post hoc analysis: Corneal healing data over time1-3,*

*In clinical trials, complete corneal healing was defined as the absence of staining of the corneal lesion and no persistent staining in the rest of the cornea at 4 and 8 weeks of treatment.

†Patients without any post-baseline measures were excluded from the analysis.

‡Post hoc analysis; results are exploratory and not powered or controlled for multiplicity. Treatment differences can be due to chance. No conclusion regarding these results can be made.

§Prespecified secondary endpoint not controlled for multiplicity. Treatment differences can be due to chance. No conclusion regarding these results can be made.

See the impact of OXERVATE

After one 8‑week course of OXERVATE, most patients achieved complete corneal healing1

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BASELINE

BASELINE

BASELINE

Images courtesy of Cecelia Koetting, OD and John Affeldt, MD.

OXERVATE was evaluated in the largest clinical trial program
of patients with neurotrophic keratitis (NK)1-3

The clinical trial program consisted of 2 multi-center,
double-masked, vehicle-controlled trials

STUDY DESIGN

3 TREATMENT ARMS
(randomized 1:1:1)
Cenegermin-bkbj 10 mcg/mL
Cenegermin-bkbj 20 mcg/mL||
Vehicle
DOSING
Dosed in the affected eye 6 times daily for 8 weeks
FOLLOW-UP
48 weeks
DIAGNOSIS
Stage 2 or Stage 3 NK
EFFICACY ANALYSIS
Complete corneal healing was defined as the absence of staining of the corneal lesion and no persistent staining in the rest of the cornea at 8 weeks of treatment

BASELINE CHARACTERISTICS

OXERVATE
20 mcg/mL (n=52)
Vehicle
(n=52)
Primary NK diagnosis, no. (%) Stage 2
Stage 3

27 (51.9)
25 (48.1)

28 (53.8)
24 (46.2)
Investigator-determined etiology,# no. (%)
Herpetic eye disease
11 (21.2)
18 (34.6)
Neurosurgical procedure (eg, acoustic neuroma, unspecified)
8 (15.4)
7 (13.5)
Dry eye disease
6 (11.5)
5 (9.6)
Ocular surgery or procedure (eg, cataract surgery/scleral buckle/vitrectomy)
5 (9.6)
7 (13.5)
Ocular surface injury/inflammation (eg, chemical burn, unspecified)
5 (9.6)
5 (9.6)
Diabetes mellitus
4 (7.7)
4 (7.7)

||The formulation that was tested 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 was seen in either of the trials.4

Unilateral.

#Not an all-inclusive list of the investigator-determined etiologies of NK in NGF0212.

STUDY DESIGN

2 TREATMENT ARMS
(RANDOMIZED 1:1)
Cenegermin-bkbj 20 mcg/mL
Vehicle
DOSING
Dosed in the affected eye(s)**6 times daily for 8 weeks
FOLLOW-UP
24 weeks
DIAGNOSIS
Stage 2 or Stage 3 NK
EFFICACY ANALYSIS
Complete corneal healing was defined as the absence of staining of the corneal lesion and no persistent staining in the rest of the cornea at 8 weeks of treatment

BASELINE CHARACTERISTICS

OXERVATE
20 mcg/mL (n=24)
Vehicle
(n=24)
Primary NK diagnosis, no. (%) Stage 2
Stage 3

15 (62.5)
9 (37.5)

18 (75.0)
6 (25.0)
Investigator-determined etiology,†† no. (%)
Herpetic eye disease
9 (37.5)
8 (33.3)
Ocular surgery or procedure (eg, anterior and posterior surgeries, cataract surgery)
3 (12.5)
4 (16.7)
Dry eye disease
3 (12.5)
3 (12.5)
Ocular surface injury/inflammation (eg, chemical burn/multiple transplant surgeries)
2 (8.3)
1 (4.2)
Neurosurgical procedure (eg, trigeminal ablation, unspecified)
1 (4.2)
1 (4.2)
Diabetes mellitus
0
1 (4.2)

**Unilateral or bilateral.

††Not an all-inclusive list of the investigator-determined etiologies of NK in NGF0214.

OXERVATE has a well-established safety profile1

  • Eye pain was the most common adverse reaction, reported in ~16% of patients
    Eye pain may arise as healing occurs
  • Other adverse reactions occurring in 1% to 10% of patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache

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Indication and 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. Bonini S, Lambiase A, Rama P, et al; REPARO Study Group. Phase II randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125(9): 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(1):14-26. 4. US Food and Drug Administration, Center for Drug Evaluation and Research. August 14, 2018. Accessed June 25, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000SumR.pdf

Indication and Important Safety Information

OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) is indicated for the treatment of neurotrophic keratitis.

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.

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