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Oxervate
Published
Product name
Oxervate
Active ingredient
Cenegermin (rbe)
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Oxervate (cenegermin (rbe)) was approved for the following therapeutic use:
Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
This indication was given orphan designation and was accepted as a priority review (see Table under What steps were involved in the decision process, below).
How this medicine works
Oxervate contains cenegermin, a recombinant form of human nerve growth factor. Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (that is, tropomyosin receptor kinase A (TrkA)) and low-affinity (that is, p75 neurotrophin receptor (p75NTR)) nerve growth factor receptors located on the anterior surface of the eye. The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Oxervate was considered favourable for the therapeutic use approved.
Sponsor