Summary
8 · Regulatory availability — summary
Review — modulators of corneal healing › Regulatory availability
✔ approved/available · ✱ off-label / compounded / hospital preparation · ✖ not approved/not available · — not applicable. "MD" = medical device.
| Agent | FDA (USA) | EU MA | France | Asia |
|---|---|---|---|---|
| Cenegermine (Oxervate) | ✔ 2018 | ✔ 2017 | ✔ | ✔ (variable) |
| Holoclar (CLET) | ✖ | ✔ 2015→2024 | ✔ (ref. centres) | ✱ analogous CLET |
| Autologous serum | ✱ compounded | ✱ national | ✱ EFS/hospital | ✱ widespread |
| PRP / PRGF | ✱ off-label | ✱ national | ✱ EFS/off-label | ✱ |
| Amniotic membrane | ✔ MD (PROKERA) / tissue | ✱ tissue (CE/bank) | ✔ tissue banks | ✔ |
| RGTA — Cacicol (human) | ✖ | ✔ MD (CE) | ✖ withdrawn | ✱ limited |
| RGTA — Clerapliq (veterinary) | ✖ | ✔ vet. MD | ✔ vet. | ✱ |
| Bandage lenses | ✔ MD | ✔ MD (CE) | ✔ | ✔ |
| Sodium hyaluronate | ✔ OTC lubricant | ✔ MD (CE) | ✔ | ✔ (major market) |
| Vitamin A (topical/syst.) | ✔ syst. / ✱ top. | ✔ | ✔ (VitA-POS) | ✔ |
| rhEGF eye drops | ✖ | ✖ | ✖ | ✔ (China…) |
| Topical insulin | ✱ off-label | ✱ off-label | ✱ hospital | ✱ |
| N-acetylcysteine | ✱ compounded | ✱ compounded | ✱ | ✱ |
| Doxycycline (anti-MMP) | ✔ (✱ corneal use) | ✔ (✱ use) | ✔ generic | ✔ |
| Topical vitamin C | ✱ compounded | ✱ | ✱ preparation | ✱ |
| Mitomycin C | ✔ (Mitosol) / ✱ cornea | ✱ hospital | ✱ intraoperative | ✱ |
| Topical losartan | ✱ off-label (oral ✔) | ✱ off-label | ✱ preparation | ✱ |
| KGF / HGF (cornea) | ✖ research | ✖ research | ✖ research | ✖ research |
| Corticosteroids / NSAIDs | ✔ | ✔ | ✔ generic | ✔ |
| Thymosin β4 (RGN-259) | ✖ phase III | ✖ | ✖ trials | ✖ (Korea dev.) |
| Nexagon (Cx43) | ✖ phase 2/3 | ✖ | ✖ | ✖ |
| CALEC | ✖ IND | — | — | — |
| MSC/exosomes · gene · PEDF · senolyt. | ✖ research | ✖ research | ✖ research | ✖ research |
Regulatory checkpoints:
• Cenegermine: EU MA (July 2017) preceded FDA approval (August 2018).
• Holoclar: EMA conditional MA on 17 February 2015 → standard MA on 22 February 2024; not FDA-approved.
• Cacicol/RGTA: the human eye-drop Cacicol has been withdrawn from the market; RGTA technology (OTR4120) remains available via the veterinary product Clerapliq (same molecule). CE-marked medical device, never a licensed medicine; not available in the USA.
• RGN-259: phase III SEER-3 was negative (June 2025) — should not be presented as effective/approved.
• Heberprot-P (Cuban rhEGF) is an injectable for the diabetic foot, not an eye drop.
• Cenegermine: EU MA (July 2017) preceded FDA approval (August 2018).
• Holoclar: EMA conditional MA on 17 February 2015 → standard MA on 22 February 2024; not FDA-approved.
• Cacicol/RGTA: the human eye-drop Cacicol has been withdrawn from the market; RGTA technology (OTR4120) remains available via the veterinary product Clerapliq (same molecule). CE-marked medical device, never a licensed medicine; not available in the USA.
• RGN-259: phase III SEER-3 was negative (June 2025) — should not be presented as effective/approved.
• Heberprot-P (Cuban rhEGF) is an injectable for the diabetic foot, not an eye drop.