What’s new in the field of serum-based eye drops

Abstract

Worldwide serum-based eye drops are successfully used in the treatment of the Dry Eye Syndrome (DES). Autologous serum eye drops (ASEDs) are most common but allogenic eye drops were introduced in many countries mostly because of the COVID-19 pandemic. Not all aspects of the product formula have however been worked out so far. Each medical entity involved in the preparation, packaging and distribution of the product performs according to its own procedures. Various actions have therefore been undertaken to standardize, harmonize and exchange the experience in this field. In 2022 the 5th edition of EDQM’s Guide to the quality and safety of tissues and cells for human application was issued. Within the EU4Health Programme a new group for Recommendations and Guidance Documents for the Management of Substances of Human Origin (SoHO) in Hospitals is being formed. International cooperation of serumbased product users lead to the establishment of working group events — Workshops on the Eye Drops of Human Origin (EDHO) and Serum eye drop manufacturer’s group. Despite the widespread use of serum-based eye drops all over the world, in almost none of the countries, EU included, are there strict legal regulations for handling the product. It is therefore necessary to come up with a universal definition of artificial tears therapy and to determine specific procedures for the product preparation.