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

Prescribing Information

Efficacy & Safety

The efficacy and safety of OXERVATE® were established in the largest combined clinical trial program conducted in patients with neurotrophic keratitis (NK).1,2

Study Design

Two 8‑week, randomized, multi-center, double‑masked, vehicle‑controlled clinical trials3

Study NGFO212 (REPARO)*1

Study NGF02142

Study Results

OXERVATE clinical trial efficacy

The efficacy and safety of OXERVATE for the treatment of NK were studied in a total of 151 patients, evaluated in two 8-week, randomized, multi-center, double-masked, vehicle-controlled studies3

Patients received study treatment dosed 6 times daily in the affected eye(s) for 8 weeks.3

Week 8

REPARO (Study NGF0212)†

Week 8

Study NGF0214

*

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.3

†

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

In patients who were healed after 8 weeks of treatment with OXERVATE, recurrences occurred in ~20% of patients in Study NGF0212 and 14% of patients in Study NGF0214.3

Clinical Outcomes

Many patients in the pivotal trials achieved complete corneal healing at week 8*3

Images are of a clinical trial patient with Stage 2 neurotrophic keratitis (NK) at baseline and week 8. Evaluations conducted by independent central reading center of the clinical images of corneal fluorescein staining. Not all patients in the trials achieved complete corneal healing.
Individual results may vary.5

Baseline6

Week 86

Complete corneal healing6

*

The efficacy and safety of OXERVATE for the treatment of neurotrophic keratitis were 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.3

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.3

Safety Profile

OXERVATE® safety in clinical trials3

  • In clinical trials, the most common adverse reaction was eye pain following instillation, which was reported in approximately 16% of patients3
  • Eye pain may arise as corneal healing occurs3
  • Other adverse reactions occurring in 1% to 10% of OXERVATE patients included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache3

Contact lenses should be removed before applying OXERVATE3

  • The presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of OXERVATE onto the area of the corneal lesion3
  • Lenses may be reinserted 15 minutes after administration3

OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. Advise patients to contact their doctor if a more serious eye reaction occurs3

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For US healthcare professionals only.

Important Safety Information

WARNINGS AND PRECAUTIONS

Contact lenses, either therapeutic or corrective, should be removed before applying OXERVATE. Contact lenses may be reinserted 15 minutes after OXERVATE administration.

Eye Discomfort, such as eye pain, that can be mild to moderate can occur with OXERVATE. Patients should contact their health care provider if a more serious eye reaction occurs.

ADVERSE REACTIONS

The most common adverse reaction with OXERVATE (~16%) was eye pain. Other adverse reactions with OXERVATE (1% to 10%) included corneal deposits, foreign body sensation, ocular hyperemia, ocular inflammation, photophobia, tearing, and headache.

Please read the full Prescribing Information for OXERVATE.

References: 1. Bonini S, Lambiase A, Rama P, et al. Phase 2 randomized, double-masked, vehicle-controlled trial of recombinant human nerve growth factor for neurotrophic keratitis. Ophthalmology. 2018;125:1332-1343. 2. Pflugfelder SC, Massaro-Giordano M, Perez VL, et al. Topical recombinant human nerve growth factor (cenegermin) for neurotrophic keratopathy: a multi-center randomized vehicle-controlled pivotal trial. Ophthalmology. 2020;127:14-26. 3. OXERVATE® (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) [US package insert]. San Mateo, CA: Dompé U.S. Inc.; 2024. 4. US Food and Drug Administration, Center for Drug Evaluation and Research. Drug Approval Package: OXERVATE (cenegermin-bkbj); Summary Review. Aug 2018. Accessed Oct 21, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000SumR.pdf 5. Data on File. Clinical Study Report (NGF0214). Dompé U.S. Inc., 2016. 6. Data on File. Clinical Study Report Addendum NGF0214. Feb 2017. Listing 16.2.6S-0.1. Patient 07004.