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Oxervate (Cenegermin-Bkbj)
Oxervate works by mimicking the natural nerve growth factor to stimulate nerve regeneration and promote healing in the cornea.
Cenegermin-Bkbj (Oxervate), marketed by Dompé Farmaceutici S.p.A., is a unique treatment for neurotrophic keratitis, a rare condition affecting corneal health. Its key strength lies in its mechanism of action, which mimics natural nerve growth factor to stimulate nerve regeneration and promote healing, setting it apart from off-patent alternatives like retinol and sodium chloride. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Cenegermin-Bkbj |
|---|---|
| Also known as | OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution, OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution, Oxervate |
| Sponsor | Dompe farmaceutici s.p.a. |
| Drug class | Recombinant Human Nerve Growth Factor [EPC] |
| Target | High affinity nerve growth factor receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
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.
Approved indications
- Neurotrophic keratitis
Common side effects
- Eye pain
- Ocular hyperemia
- Eye inflammation
- Increased lacrimation
- Corneal deposits
- Foreign body sensation
- Ocular inflammation
- Tearing
Key clinical trials
- DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
- Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis (PHASE4)
- DOMPE -MT Neurotrophic Keratitis (PHASE4)
- Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis (PHASE4)
- OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
- NGF Treatment for Patients With Neuropathic Corneal Pain (PHASE1)
- Nerve Growth Factor for the Treatment of Cornea Disease
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |