A protocol for processing amniotic membrane as an extract to be re-hydrated and administered topically as eye drops (amniotic membrane extract eye drops, AMEED) has been developed. Safety and efficacy of AMEED was assessed in patients with severe ocular surface pathologies. prospective clinical follow-up of ocular surface symptoms before and after regular application of the AMEED for at least 4 weeks on patients with severe ocular surface disorders as chronic dry eye disease, limbal stem cell deficiency, neurotrophic ulcer and permanent and disabling symptomatology that were refractory to conventional treatment. Efficacy and tolerability were assessed based on patient-reported symptoms, objective measurements, and reports of adverse events. Thirty-six eyes from 25 patients were included. Although the visual quality function score, by means of a VQF25 questionnaire, was not statistically different after the treatment (p = 0.4657), there was a clear trend, statistically significant, towards the improvement in ocular symptoms like foreign body sensation, itching and stinging (p < 0.05) and clinical presentation of the pathology. All patients with corneal ulcer showed complete epithelization. Topically applied AMEED proved to be safe, well tolerated and effective in reducing the symptoms and clinical signs of severe ocular disease. Further studies are needed to confirm the best indications for AMEED use.
Keywords: Amnion; Dry eye disease; Ophthalmic solutions; Tissue bank.
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