1 · Growth factors & blood derivatives
Cenegermine — recombinant human NGF · OXERVATE®
Review — modulators of corneal healing › 1 · Growth factors & blood derivatives › Cenegermine — recombinant human NGF · OXERVATE®
Cenegermine — recombinant human NGF · OXERVATE®
INN cenegermin (US: cenegermin-bkbj) · Dompé · first-in-class rhNGF
Oxford I–II
Strong
Present · MA
Mechanism of actionRecombinant human NGF (produced in E. coli) binding the high-affinity TrkA receptor and the low-affinity p75NTR receptor (epithelium, keratocytes, sensory nerve endings). Restores neurotrophic support: epithelial proliferation/differentiation, corneal nerve regeneration and reinnervation.
IndicationsModerate to severe neurotrophic keratitis (stages 2–3: PED and ulcer). Only approved indication.
Route & dosageEye drops 0.002% (20 µg/mL) · 1 drop 6×/day (~every 2 hours during waking hours) for 8 weeks. Cold chain, dedicated multidose delivery system.
Level of evidenceOxford I–II / GRADE moderate–high · Scale: Strong (for neurotrophic keratitis). Multicenter double-masked RCTs versus vehicle.
| FDA | Approved (August 2018) — BLA, orphan drug; neurotrophic keratitis. 1st FDA-approved drug for this disease. |
|---|---|
| EU MA | Approved (EC MA July 2017; CHMP opinion May 2017) — moderate to severe neurotrophic keratitis in adults. (The EU preceded the US.) |
| France | Available (EU marketing authorisation; hospital/specialty circuit, HAS evaluation). |
| USA | Available (marketed). |
| Asia | Approval/access varies by market (gradual adoption, e.g. Japan) + early access. |
Key studies: REPARO (NGF0212), Bonini S et al., Ophthalmology 2018 (~72% healing at 8 wk vs ~33% vehicle) — PMID 29653858; NGF0214, Pflugfelder SC et al., Ophthalmology 2020 (69.6% vs 29.2%) — PMID 31585826.
See also: Gabison E. “Corneal wound-healing agents”. In: SFO 2023 Report — Médicaments et biothérapies en ophtalmologie, chapter 21. Full text, open access (in French).