Or iginal s tud y Serum eye drops SA
Autumn 2021 • Vol 16 | No 2 SA Ophthalmology Journal
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Serum eye drops: a South African perspective TN Glatt MBBCh, FCPath Haematology, MMed Haematology; Cell processing and manipulation specialist, Cellular Therapy ORCID: https://orcid.org/0000-0002-5458-5791 B Rhode BTech; Head: Cellular Therapy Laboratory R Cockeran PhD; Head: Cell Processing and Growth Laboratories ORCID: https://orcid.org/0000-0001-9227-6124 C Poole MBChB; Lead consultant: Cellular Therapy and Novel Products ORCID: https://orcid.org/0000-0002-7077-4859 Department of Cellular Therapy and Novel Products, South African National Blood Service, Johannesburg, South Africa Corresponding author: Dr Tanya Glatt, SANBS, 1 Constantia Boulevard, Constantia Kloof, 1709; tel: 011 761 9000; email: tanya.glatt@sanbs.org.za
Abstract Background: Serum eye drops are used in the management of severe ocular surface diseases including dry eye syndrome. These eye drops are produced from the serum component of autologous or allogeneic blood donations. Methods: This manuscript describes the manufacturing process, quality control and biochemical content of serum eye drops produced by the South African National Blood Service (SANBS), as well as questionnaire-based feedback from patients using this product. Results: SANBS eye serum production and quality control is in line with international practices. The patient feedback shows that the use of these eye drops significantly improves dry and painful eyes, overall quality of life and the execution of daily tasks.
Introduction
Internationally the use of blood-derived products as a therapeutic modality for severe ocular surface disease (OSD) has increased significantly in recent years.1,2 This treatment option includes serum eye drops (SEDs) produced from the patient’s own blood (autologous blood donation) or from an alternate (allogeneic) blood donation. Dry eye syndrome is the most common condition treated with SEDs. 3 Other documented conditions include persistent corneal epithelial defects, limbal stem cell deficiency, corneal ulcers, chemical burns, recurrent corneal erosions, ocular surface involvement of Stevens-Johnson syndrome and graft versus host disease. 2,4 SEDs are also useful in the management of postoperative recovery after surface-based corneal laser refractive procedures. In general,
Conclusion: We can therefore conclude that SANBS produces high quality serum eye drops, which are in line with international published content investigations and which meet patient expectations. Keywords: serum, eye drops, dry eye syndrome, therapy, ocular surface disease Funding: No financial support was received by any of the authors for performing this research. Conflict of interest: The authors have no conflicts of interest to declare.
SEDs are reserved for patients who are non-responsive or partially responsive to standard therapy or where prompt recovery of a corneal epithelial defect is required. 2 The safety of SEDs and their effect on corneal epithelial cell migration and proliferation are well established. 5-7 The benefit of SEDs is two-fold: first, they act as a physical replacement to natural tears by offering lubrication of the ocular surface, and secondly, as a biochemical replacement to natural tears due to growth factor and cytokine content which aid ocular surface repair. 8-11 SEDs are typically produced by blood services as part of their extended programme of operation as blood services have the infrastructure to collect, test and process blood products to ensure adequate quality standards are
maintained throughout the production process.12 The South African National Blood Service (SANBS) has been producing SEDs in South Africa since 2002. This manuscript serves to report on the production, biochemical properties and patient-reported efficacy of the SEDs produced by SANBS.
Methods
The study was approved by the SANBS Human Research Ethics Committee (registration number: REC-270606-013, clearance certificate number: 2020/0539).
Study setting and SED production Patients suffering from severe OSD who have failed standard therapy or who are recovering from surface-based corneal laser refractive procedures are potential candidates for SED therapy.
