OXERVATE
Peakcenegermin-bkbj
BLAOPHTHALMICSOLUTIONPriority Review
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
5/8 — Partial
Priority Review
OXERVATE (cenegermin-bkbj) is neurons, which acts through specific high-affinity (i. Approved for neurotrophic keratitis. First approved in 2018.
OXERVATE (cenegermin-bkbj) is a recombinant human nerve growth factor (NGF) ophthalmic solution approved by the FDA in August 2018 for the treatment of neurotrophic keratitis. It works by binding to high-affinity (TrkA) and low-affinity (p75NTR) nerve growth factor receptors in the anterior segment of the eye to support corneal innervation and integrity. This represents the first and only FDA-approved NGF therapy for corneal nerve regeneration, filling a significant unmet need in a rare orphan indication with limited treatment options.
$0.5BPart D
Mechanism of Action
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.
Pharmacologic Class:
Recombinant Human Nerve Growth Factor
Indications (1)
Clinical Trials (4)
Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease
Started Jan 2022
85 enrolled
Dry Eye Disease
Safety and Efficacy Study on Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PROTEGO-1 Study)
Started Jan 2022
104 enrolled
Dry Eye
OCT Evaluation of Neurotrophic Ulcer Following Treatment With Oxervate
Started Oct 2020
10 enrolled
Neurotrophic UlcerNeurotrophic KeratitisNeurotrophic Corneal Ulcer+1 more
Study to Evaluate OXERVATE® in Patients With Stage 1 Neurotrophic Keratitis
Started Sep 2020
37 enrolled
Neurotrophic Keratitis
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.