Cenegermin

Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.

• OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis.

• None. None.contraindicated

One drop of OXERVATE in the affected eye(s), 6 times per day at 2-hour intervals, for eight weeks. ( 2.1 ) 2.1 General Dosing Information 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 one 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. 2.2 Recommended Dosage and Dose Administration Instill one drop of OXERVATE in the affected eye(s), 6 times a day at 2-hour intervals for eight weeks. 2.3 Preparation for Administration 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. Follow Steps 1 to 19 each day you use OXERVATE: Take an individual vial of OXERVATE from the refrigerator in the morning and prepare it in the following way: Step 1. Wash your hands. Step 2. If you wear contact lenses, take them out before using OXERVATE. Step 3. Remove the plastic flip-off cap from the vial. Step 4.

Patients should remove contact lenses before applying OXERVATE and wait 15 minutes after instillation of the dose before reinsertion. ( 5.1 ) 5.1 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. 5.2 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.

The most common adverse reactions (incidence >5%) are eye pain, ocular hyperemia, eye inflammation and increased lacrimation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dompé U.S. Inc. at 1-833-366-7387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In two clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95). The majority of the treated patients were female (61%). 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. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of OXERVATE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

8.1 Pregnancy Risk Summary There are no data from the use of OXERVATE in pregnant women to inform any drug associated risks. Administration of cenegermin-bkbj to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses. In a pre- and postnatal development study, administration of cenegermin-bkbj to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses. Data Animal Data In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in post-implantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the MRHOD). A no observed adverse effect level (NOAEL) was not established for post-implantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed each in one fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart and aortic arch dilation were observed each in one fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

Metabolism

Systemic exposure to cenegermin-bkbj was evaluated by measuring serum nerve growth factor (NGF) concentrations in 20 healthy subjects who received single and multiple (up to six times a day) administration of one drop (35 μL) OXERVATE (0.70 μg of cenegermin-bkbj/administration). The study also included a placebo arm in 10 healthy subjects who received vehicle only.

• Aug 22, 2018BLABLA761094Dompe Farmaceutici

1. 1Eye Pain5,85649%
2. 2Eye Irritation1,87516%
3. 3Product Dose Omission Issue1,34611%
4. 4Ocular Hyperaemia1,22910%
5. 5Photophobia1,0678.9%
6. 6Vision Blurred9497.9%
7. 7Wrong Technique In Product Usage Process9027.5%
8. 8Eye Swelling8497.1%
9. 9Ocular Discomfort7996.7%
10. 10Lacrimation Increased7386.2%
11. 11Eyelid Pain7075.9%
12. 12Headache6745.6%
13. 13Product Administration Error6165.1%
14. 14Dry Eye5414.5%
15. 15Off Label Use5244.4%

The 10 most recently updated of 25 ClinicalTrials.gov registrations naming Cenegermin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
  Recruiting · Phase 3 · Interventional · 150 enrolled · Dompé Farmaceutici S.p.A
  NCT07519902updated 2026-06-05
• Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
  Not yet recruiting · Phase 3 · Interventional · 272 enrolled · Dompé Farmaceutici S.p.A
  NCT07453888updated 2026-04-20
• A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease.
  Completed · Phase 2 · Interventional · 317 enrolled · Dompé Farmaceutici S.p.A
  NCT06244316updated 2026-02-13
• DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
  Completed · Observational · 24 enrolled · Dompé Farmaceutici S.p.A
  NCT05552261updated 2025-11-28
• Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease
  Completed · Phase 3 · Interventional · 85 enrolled · Dompé Farmaceutici S.p.A
  NCT05136170updated 2025-11-26
• Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
  Completed · Phase 4 · Interventional · 37 enrolled · Dompé Farmaceutici S.p.A
  NCT04485546updated 2025-11-17
• Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study
  Not yet recruiting · Interventional · 10 enrolled · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
  NCT07073729updated 2025-07-18
• DOMPE -MT Neurotrophic Keratitis
  Active not recruiting · Phase 4 · Interventional · 10 enrolled · Toyos Clinic
  NCT06947850updated 2025-04-27
• Corneal Nerves After Treatment With Cenegermin
  Completed · Observational · 8 enrolled · University of California, Los Angeles
  NCT04627571updated 2025-04-01
• Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis
  Withdrawn · Phase 4 · Interventional · 0 enrolled · Dompé Farmaceutici S.p.A
  NCT06411145updated 2024-12-02

Frequently asked questions

How does Cenegermin work?

Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (i.e., TrkA) and low-affinity (i.e. p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity.

What is Cenegermin used for?

According to FDA labeling, Cenegermin carries indications including: OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is a recombinant human nerve growth factor indicated for the treatment of neurotrophic keratitis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cenegermin?

Cenegermin is classified as Other ophthalmologicals, Recombinant Human Nerve Growth Factor, Increased Sensory-Somatic Nervous System Nerve Growth Factor Activity.

What are the brand names for Cenegermin?

Cenegermin is marketed under brand names including Oxervate.

What are the contraindications for Cenegermin?

Cenegermin labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.