Results of adjunctive homogenate amniotic membrane eye drops in the management of refractory ocular surface disease with dry eye manifestations

Purpose To evaluate clinical outcomes of adjunctive treatment with homogenate human amniotic membrane eye drops (AMED) in patients with refractory ocular surface disease with dry eye (DE) manifestations Methods We retrospectively reviewed patients' medical records, ocular surface images, and instrumental data related to Schirmer I test, Oxford and Efron grading, non-invasive tear break-up time, Ocular Surface Disease Index (OSDI), adverse events, and symptom recurrence after discontinuation. All patients were assessed for safety while the efficacy analysis included patients who completed 2-month uninterrupted AMED treatment, without modification of topical or systemic therapy in the previous two months or during the treatment period. Results A total of 160 patients were exposed to AMED. Twenty-three (14.4%) patients discontinued treatment and 25 (15.6%) showed adverse events. 112 (70%) patients [mean (SD) age 57 (16) years], 73.0% female, were included in the efficacy analysis. We observed improvement in corneal Oxford grading in graft-versus-host disease (GVHD) and limbal stem cell deficiency (LSCD) patients (P < 0.001 and P = 0.02, respectively) and conjunctival Oxford grading in GVHD, LSCD, Sj & ouml;gren's syndrome (SS) and non-Sj & ouml;gren's dry eye (NSDE) (P < 0.001); decreasing in Efron score in GVHD and SS (P < 0.001 and P = 0.03, respectively). Tear film stability improved across almost all groups and OSDI showed clinically modest changes. Symptoms recurrence was reported in 86.9% of patients within one month after AMED discontinuation without adverse events reported during 2-month continuous treatment. Conclusions Adjunctive AMED treatment was associated with objective improvements of ocular surface, with limited effects on symptoms, likely reflecting the multifactorial nature of DE manifestations across clinically and pathophysiological distinct entities.