TY - JOUR
T1 - Eye drops of human origin—Current status and future needs
T2 - Report on the workshop organized by the ISBT Working Party for Cellular Therapies
AU - Gabriel, Christian
AU - Marks, Denese C.
AU - Henschler, Reinhard
AU - Schallmoser, Katharina
AU - Burnouf, Thierry
AU - Koh, Mickey B.C.
N1 - Publisher Copyright:
© 2023 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.
PY - 2023
Y1 - 2023
N2 - Background and Objectives: Serum eye drops (SEDs) are used to treat ocular surface disease (OSD) and to promote ocular surface renewal. However, their use and production are not standardized, and several new forms of human eye drops have been developed. Materials and Methods: The International Society for Blood Transfusion Working Party (ISBT WP) for Cellular Therapies held a workshop to review the current types of eye drops of human origin (EDHO) status and provide guidance. Results: The ISBT WP for Cellular Therapies introduced the new terminology ‘EDHO’ to emphasize that these products are analogous to ‘medical products of human origin’. This concept encompasses their source (serum, platelet lysate, and cord blood) and the increasingly diverse spectrum of clinical usage in ophthalmology and the need for traceability. The workshop identified the wide variability in EDHO manufacturing, lack of harmonized quality and production standards, distribution issues, reimbursement schemes and regulations. EDHO use and efficacy is established for the treatment of OSD, especially for those refractory to conventional treatments. Conclusion: Production and distribution of single-donor donations are cumbersome and complex. The workshop participants agreed that allogeneic EDHO have advantages over autologous EDHO although more data on clinical efficacy and safety are needed. Allogeneic EDHOs enable more efficient production and, when pooled, can provide enhanced standardization for clinical consistency, provided optimal margin of virus safety is ensured. Newer products, including platelet-lysate- and cord-blood-derived EDHO, show promise and benefits over SED, but their safety and efficacy are yet to be fully established. This workshop highlighted the need for harmonization of EDHO standards and guidelines.
AB - Background and Objectives: Serum eye drops (SEDs) are used to treat ocular surface disease (OSD) and to promote ocular surface renewal. However, their use and production are not standardized, and several new forms of human eye drops have been developed. Materials and Methods: The International Society for Blood Transfusion Working Party (ISBT WP) for Cellular Therapies held a workshop to review the current types of eye drops of human origin (EDHO) status and provide guidance. Results: The ISBT WP for Cellular Therapies introduced the new terminology ‘EDHO’ to emphasize that these products are analogous to ‘medical products of human origin’. This concept encompasses their source (serum, platelet lysate, and cord blood) and the increasingly diverse spectrum of clinical usage in ophthalmology and the need for traceability. The workshop identified the wide variability in EDHO manufacturing, lack of harmonized quality and production standards, distribution issues, reimbursement schemes and regulations. EDHO use and efficacy is established for the treatment of OSD, especially for those refractory to conventional treatments. Conclusion: Production and distribution of single-donor donations are cumbersome and complex. The workshop participants agreed that allogeneic EDHO have advantages over autologous EDHO although more data on clinical efficacy and safety are needed. Allogeneic EDHOs enable more efficient production and, when pooled, can provide enhanced standardization for clinical consistency, provided optimal margin of virus safety is ensured. Newer products, including platelet-lysate- and cord-blood-derived EDHO, show promise and benefits over SED, but their safety and efficacy are yet to be fully established. This workshop highlighted the need for harmonization of EDHO standards and guidelines.
KW - eye drops of human origin
KW - ocular surface disease
KW - serum eye drops
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U2 - 10.1111/vox.13413
DO - 10.1111/vox.13413
M3 - Article
C2 - 36847186
AN - SCOPUS:85149962324
SN - 0042-9007
VL - 118
SP - 301
EP - 309
JO - Vox Sanguinis
JF - Vox Sanguinis
IS - 4
ER -