OXERVATE
Peakcenegermin-bkbj
BLAOPHTHALMICSOLUTIONPriority Review
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
OXERVATE (cenegermin-bkbj) is neurons, which acts through specific high-affinity (i. First approved in 2018.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OXERVATE (cenegermin-bkbj) is a recombinant human nerve growth factor (NGF) ophthalmic solution approved by the FDA in August 2018. It works by binding to TrkA and p75NTR receptors on corneal neurons to promote innervation and corneal integrity. The drug treats neurotrophic keratopathy (NK), a rare corneal disease characterized by reduced corneal sensation and progressive epithelial breakdown.
$493MPart D
PeakPeak lifecycle status with substantial Medicare/Medicaid spending (~$493M in 2023) suggests a mature, established brand with stable commercial infrastructure and established field teams.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.