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BMJ Open Ophthalmol
BMJ Open Ophthalmol
bmjophth
bmjophth
BMJ Open Ophthalmology
2397-3269
BMJ Group BMA House, Tavistock Square, London, WC1H 9JR

37282681
bmjophth-2022-EEBA.30
10.1136/bmjophth-2022-EEBA.30
Oral abstracts
Theme 6 – Clinical outcome monitoring and transplantation registries
1506
30 A new step on amniotic membrane extract eye drops (AMEED) development for the treatment of severe ocular surface pathologies
Agusti Elba 1
Martinez-Conesa Eva M 1
Perez Maria Luisa 1
Sabater-Cruz Noelia 12
Casaroli-Marano Ricardo P 12
Vilarrodona Anna 1
1 Barcelona Tissue Bank, Barcelona, Spain
2 Hospital Clínic, Barcelona, Spain
2022
16 11 2022
7 Suppl 2 Abstracts of the European Eye Bank Association Virtual Meeting, 3–5 March 2022 A13A13
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
2022
https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

Introduction

Our tissue establishment developed a protocol for processing amniotic membranes as extracts to be re-hydrated and administered topically as eye drops, becoming a new approach to treat severe ocular surface pathologies. From 2015 to 2017 the safety and efficacy of the amniotic membrane extract eye drops (AMEED) were assessed in patients with severe ocular surface pathologies through clinical follow-up of ocular surface symptoms before and after regular application of the extract.

Between 2018 and 2019 a study of 36 patients (50 eyes) treated with topical AMEED was conducted comparing 2 groups of patients: Dry Eye Disease (DED) and Wound Healing Delay (WHD) showing global similar symptomatic improvement in both groups (DED 88.9% vs WHD 100%; p= 0.486) with the WHD group especially consisting in general relief (78%) and DED group reporting more pain improvement (44%) (p=0.011). Regarding patients with autologous serum as previous treatment, no statistical differences were found in subjective or objective improvement. An overall success was achieved in 94.4% of the cases and no adverse events were found. From January 2020 to November 2021 a growth stage has been observed including more patients while optimizing and scaling the process from donation to clinical use.

Materials and Methods

We record data of placenta donation and preparation of AMEED vials from 1/1/2020 to 30/11/2021 and its clinical use including the indications for treatment, number of requesting ophthalmologists and number of patients.

Results

In the study period a total of 378 placentas were processed to obtain AMEDD (61 in 2020 and 317 in 2021). The number of suitable vials obtained were: 1845 and 6464 respectively and 1946 vials are stored in quarantine pending release for clinical use.

A total of 9365 vials were sent for treatment of ocular surface pathologies to 31 hospitals (98% in Catalonia) and 69 requesting ophthalmologists.

The total number of patients treated was 204 and the indications for treatment were 82% DED and 18% WHD.

Conclusion

After the new product development and introduction stages, a significant increase in the use of AMEED in Catalan hospitals was observed in 2020-2021. Follow-up data of these patients should be assessed to demonstrate its efficacy and achieve the maturity stage.

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