Drug intelligence / Profile preview

amniotic membrane extract

Development stage
Phase 3
Lead developer
BioTissue
Administration
Ophthalmic, Topical
01

Overview

Amniotic membrane extract (AME) is a therapeutic product derived from the amniotic membrane, which is the innermost layer of the placenta. It contains numerous bioactive components that contribute to its healing properties, making it valuable for various medical applications, particularly in ophthalmology. ## Composition and Properties AME contains many of the same properties as cryopreserved amniotic membrane, including high levels of growth factors such as epithelial growth factor (EGF), hepatocyte growth factor (HGF), basic fibroblast growth factor (bFGF), and protease inhibitors[1][5]. It also contains a novel matrix component known as heavy chain-hyaluronan pentraxin 3 (HC-HA/PTX3), which helps prevent inflammation, angiogenesis, and scarring[1][5]. The extract retains anti-inflammatory activities and often works by downregulating and inducing apoptosis in macrophages[1][5]. These properties make AME effective in promoting healing after injury due to inflammation, infection, or trauma. ## Medical Applications ### Ophthalmology AME is primarily used in ophthalmology, where it can be formulated as eye drops (AMEED) to provide continuous delivery of growth factors and cytokines for corneal healing[8]. It has shown effectiveness in treating: - Corneal ulcers and erosions - Chemical and thermal burns - Limbal stem cell deficiency (LSCD) - Peripheral corneal ulcers (such as Terrien's and Mooren's) - Dry eye disease - Post-surgical healing (after procedures like PRK and limbal transplants)[5] The anti-inflammatory, regenerative, and antimicrobial properties of AME make it valuable for treating various ocular surface disorders[8]. ### Other Applications While the search results focus primarily on ophthalmic applications, they also mention that AME supports wound healing, particularly for diabetic ulcers, by promoting healing and reducing scarring and inflammation[4]. ## Preparation Methods AME is derived from human placenta collected from pre-selected donors following cesarean section. The donors undergo screening for various infectious diseases, including HIV, hepatitis, and cytomegalovirus[2]. The preparation process typically involves: 1. Washing the placenta with saline solution 2. Separating the amniotic membrane 3. Treating with antibiotics 4. Processing through various methods (cryopreservation, lyophilization, or extraction)[2] For eye drops specifically, the amniotic membrane is processed to extract its bioactive components, which are then formulated into a solution suitable for topical application[8]. ## Mechanism of Action AME works through multiple mechanisms: 1. **Anti-inflammatory effects**: Downregulates proinflammatory cytokines and induces apoptosis in macrophages[1][5][8] 2. **Promotion of epithelial growth**: Contains growth factors that stimulate cell migration, adhesion, and differentiation[10] 3. **Anti-scarring properties**: Inhibits fibroblast growth and reduces scarring through components like HC-HA/PTX3[1][5] 4. **Antimicrobial activity**: Provides protection against infection[10] 5. **Tissue regeneration**: Supports healing and restoration of damaged tissues[7] These mechanisms make AME particularly effective for treating conditions involving inflammation, tissue damage, and impaired healing.

Brand names
RegenesolGenesisRegener-Eyes
Other names
AMEAMEEDamniotic membrane extract eye drops
02

Targets

MET (Mesenchymal-epithelial transition factor receptor)ERBB2 (Erb-b2 receptor tyrosine kinase 2)FGFR (FGFR family)

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