1 · Growth factors & blood derivatives
Autologous serum (eye drops) — ASED
Review — modulators of corneal healing › 1 · Growth factors & blood derivatives › Autologous serum (eye drops) — ASED
Autologous serum (eye drops) — ASED
Preparation derived from the patient's own blood (no INN or brand name) · diluted 20–100% in physiological saline
Oxford II–III
Moderate
Present · established
Mechanism of actionBiological tear substitute: provides EGF, TGF-β, PDGF, NGF, IGF-1, fibronectin, vitamin A, substance P + anti-proteases (α2-macroglobulin, TIMP) and antimicrobial factors (lysozyme, IgG) at near-physiological concentrations. Promotes epithelial migration/proliferation/differentiation and neurotrophic support.
IndicationsPersistent epithelial defects (PED), severe/refractory dry eye (Sjögren, GVHD), neurotrophic keratopathy, recurrent erosions, burns, post-LASIK/PRK.
Route & dosageTopical. Usual concentrations 20% and 50% (100% for refractory PED); 4 to 8×/day, up to hourly in acute PED. Frozen aliquots (−20 °C, ~3–6 months); vial in use ~1 week at +4 °C.
Level of evidenceOxford II–III / GRADE weak–moderate · Scale: Moderate. Small RCTs + numerous case series; solid for dry eye symptoms, more pragmatic for PED (lack of large RCTs).
| FDA | Not approved — compounded preparation (individualized biologic, 503A/503B). |
|---|---|
| EU MA | No — no centralized medicinal product; nationally regulated as a blood-derived product. |
| France | Available — prepared by the EFS (French Blood Establishment) / hospital pharmacies under ANSM/EFS oversight. |
| USA | Available via compounding pharmacies / eye banks (often not reimbursed). |
| Asia | Widespread hospital use (Japan, South Korea, Taiwan, India, Thailand). |
Key studies: He et al., meta-analysis of RCTs in dry eye, Front Med 2024 — PMID 39346942; AAO Ophthalmic Technology Assessment, Ophthalmology 2020 — PMID 31561880; Poon/Geerling (reference protocol), Br J Ophthalmol 2001 — PMID 11567963.
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).