Cenegermin

Summary

Cenegermin (Oxervate) is a recombinant human nerve growth factor approved for the treatment of moderate to severe neurotrophic keratitis in adults. It is administered as eye drops and promotes corneal healing by restoring neurotrophic support to the corneal epithelium. It was the first treatment specifically approved for neurotrophic keratitis.

Mechanism of Action

Cenegermin is a recombinant form of human nerve growth factor (NGF) that binds to TrkA and p75NTR receptors on corneal epithelial cells, stromal keratocytes, and sensory neurons, promoting corneal epithelial cell proliferation, migration, differentiation, and survival, thereby supporting corneal nerve regeneration and healing in neurotrophic keratitis.

Routes of Administration

Goals & Uses

• Healing of neurotrophic keratitis corneal ulcers/epithelial defectsTherapeuticHigh
• Restoration of corneal sensitivityTherapeuticModerate
• Corneal nerve regenerationTherapeuticModerate
• Prevention of disease progression to corneal perforationTherapeuticModerate

Contraindications

• Active ocular or periocular infection not adequately treatedInfectiousModerate
• Hypersensitivity to cenegermin or any excipientAllergic/ImmunologicHigh

Adverse Effects

• Increased lacrimationOcularCommon
• Foreign body sensationOcularCommon
• Ocular hyperemia (conjunctival redness)OcularCommon
• Corneal depositsOcularCommon
• Ocular inflammationOcularUncommon
• Eye painOcularCommon

Drug Interactions

• Benzalkonium chloride-containing eye dropsModerate
• Other ophthalmic medicationsLow

Population Constraints

• Pediatric patients (under 18 years)AgeRelative
• Contact lens wearersDevice InteractionRelative
• Pregnant or breastfeeding womenReproductiveRelative

Regulatory Status

• European UnionApprovedApproved: Moderate to severe neurotrophic keratitis in adultsEMA approved July 2017; orphan medicinal product designation; first-in-class approval for this indication.
• United StatesApprovedApproved: Moderate to severe neurotrophic keratitis in adultsFDA approved August 2018; orphan drug designation; marketed as Oxervate by Dompé.
• United KingdomApprovedApproved: Moderate to severe neurotrophic keratitis in adultsApproved under MHRA following EU approval; retains orphan designation post-Brexit.

Approved by the EMA in 2017 and the FDA in 2018 for moderate to severe neurotrophic keratitis. Designated as an orphan drug in both the EU and US given the rarity of the condition.

Evidence & Sources

No sources recorded yet.