Cenegermin

Overview

The first drug ever approved for neurotrophic keratitis, a degenerative disease in which the cornea loses its nerve supply and stops healing. It is a growth factor delivered as an eye drop, and it heals corneal ulcers that previously required surgery.

How it works

Recombinant human NGF binds TrkA and p75 receptors on corneal epithelial cells, sensory nerve endings and limbal stem cells, restoring the trophic signalling that maintains corneal integrity. Because the cornea and its nerves are damaged in the same disease process, supplying NGF supports both.

Evidence base

Rated 5 of 5 — Very strong. Multiple phase 3 randomized trials plus regulatory approval in a major market.

• Two randomized vehicle-controlled phase 3 trials with an objective imaging-confirmed endpoint.

Benefits & potential uses

Bars indicate how well each claim is supported: three = strong human evidence, two = moderate, one = preliminary or preclinical.

• Heals persistent corneal defects Strong evidence

  Roughly 70% of treated patients achieved complete corneal healing at 8 weeks versus far fewer on vehicle, in randomized trials.

• First approved therapy for the condition Strong evidence

  Previously management was limited to lubricants, bandage lenses and surgical options such as tarsorrhaphy.

• Durable healing Moderate evidence

  Follow-up showed most healed patients remained healed after treatment ended.

• Restores corneal sensitivity in some patients Moderate evidence

  Consistent with genuine nerve regeneration rather than surface healing alone.

Risks, cons & cautions

Bars indicate seriousness: three = serious or common, two = moderate, one = minor.

• Eye pain during treatment Moderate evidence

  The most common adverse effect, and mechanistically expected — restored corneal sensation in a previously anaesthetic eye is uncomfortable.

• Demanding regimen Moderate evidence

  Six drops daily for eight weeks, with strict cold-chain handling and a specific administration schedule. Adherence is a genuine problem.

• Ocular hyperaemia and inflammation Minor

  Common, generally resolving after the treatment course.

• Very high cost Moderate evidence

  Among the most expensive ophthalmic treatment courses available.

• Narrow indication Moderate evidence

  Approved only for neurotrophic keratitis; there is no evidence for use in ordinary dry eye.

Who should avoid it

• Use for conditions other than neurotrophic keratitis
• Contact lens wear during treatment
• Known hypersensitivity to the formulation

If used under medical supervision, monitor

• Corneal healing by slit-lamp examination
• Corneal sensitivity testing
• Symptom assessment during the 8-week course

Interactions

Not exhaustive. Always have a pharmacist or physician review your full medication list — including supplements.

• No significant systemic interactions
• Other eye drops — separate instillation by at least 15 minutes

Regulatory & legal status

Prescription ophthalmic drug, supplied through specialty distribution with cold-chain requirements.

Infographic

Cenegermin — benefits & risks at a glance Download SVG

Where to read further

We link to live literature searches rather than a frozen citation list, so you always see current results — including anything published after our last review.

• PubMed — all published literature on Cenegermin
• PubMed — randomized controlled trials only
• ClinicalTrials.gov — registered human trials
• DailyMed — official FDA prescribing information

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