VENDAJE OPTIC | BioStem Technologies

VENDAJE™️ OPTIC is a dehydrated human amniotic membrane allograft that is used to treat a range of ocular conditions. Amniotic membrane transplantation has been used safely and effectively to treat corneal ulcers and persistent corneal epithelial defects for more than two decades, and new applications for reconstructive and regenerative ophthalmology continue to be described1.
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VENDAJE™️ OPTIC dehydrated human amniotic membrane allografts provide the full spectrum of bioactive compounds that are found in the intact amniotic membrane, and they are aseptically processed and terminally sterilized, making them suitable for use in even the most delicate surgeries. And since it is non-immunogenic, VENDAJE™️ OPTIC doesn’t lead to inflammation or excessive immune responses. The result is consistently high patient success and improved clinical outcomes.

The amniotic membrane is the innermost layer of the placental membranes, and it is composed of the epithelial monolayer, basement membrane and stroma. The complex extracellular matrix (ECM) that forms these layers provides a bioactive scaffold for tissue regeneration, and it is chock full of collagens, laminin, fibronectin, and proteoglycans, which are integral to tissue regeneration and wound healing2.

Amniotic membranes also have multipotent epithelial and mesenchymal stem cells that secrete paracrine-acting cytokines and growth factors to induce tissue development without eliciting an immune response. Epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), transforming growth factors alpha and beta (TGF‐α and TGF‐β), and nerve growth factor (NGF) are present in large amounts in the membrane3, and drive tissue regeneration and development. Immunosuppressive interleukins 4 and 10 (IL-4 and IL-10) and prostaglandin E2 (PGE2) suppress B and CD4+ and CD8+ T cell activation, inhibit the release of pro-inflammatory IFN-γ, and promote anti-inflammatory M2 macrophage activation4-5.

Amniotic membranes are becoming a standard treatment option for corneal abrasions and other injuries that require a physical barrier to protect the conjunctival and corneal epithelia1. In addition to providing the physical protection of a bandage, they deliver anti-inflammatory, anti-microbial, and anti-angiogenic properties. Moreover, the amniotic membrane’s ECM contains large amounts of hyaluronic acid, which promotes non-fibrotic healing6. These qualities mean that patients heal faster, have less pain and inflammation, and less scarring.

As a surgical graft, VENDAJE™️ OPTIC is integrated into the corneal stroma as non-fibrotic re-epithelization occurs, which reduces the risk for future complications that are associated with scarring. The amniotic discs can be sutured or secured with cyanoacrylate glue7, and they are available in a number of sizes to accommodate a variety of conditions.

The impressive success of amniotic membranes in treating notoriously challenging cases underscores the therapeutic benefit they deliver. A recent clinical report found that the implantation of a human amniotic membrane patch successfully improved visual acuity recovery in patients with serous macular detachment associated with optic nerve head pit8. Similarly, early use of amniotic membrane treatment in acute Stevens-Johnson syndrome/toxic epidermal necrolysis was found to mitigate severe vision loss several months after patient discharge9. Recurrent corneal erosion is also significantly improved after amniotic allograft treatment10.

VENDAJE™️ OPTIC is indicated for corneal and conjunctival surface reconstruction and can be used in conjunction with other surgeries. Amniotic membrane allografts have been shown to speed healing and suppress excessive immune responses, making them a valuable treatment option for a range of conditions, including degenerative diseases (including neurotrophic keratitis11), traumatic injuries, and autoimmune disorders.

VENDAJE™ OPTIC Key Points

Acts as a physical barrier and protects the epithelium as it heals.
Reduces pain caused by friction of the eyelids over the damaged surface.
Applied directly to the eye and requires no surgical incisions for treatment
Adheres naturally to the patient's eye via hydrostatic tension
No blood typing or donor matching required
No orientation issues, can be applied on either side

Contains full spectrum of growth factors
Biocompatible scaffold with extracellular matrix
No Immune Rejection
Moderate levels of fibronectin and laminin
Anti-fibrotic and anti-adhesion barrier
High tensile strength

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References
1. Rock, T., et al., Amniotic Membrane Transplantation in Reconstructive and Regenerative Ophthalmology. Ann Transplant, 2018. 23: p. 160-165.
2. Olczyk, P., L. Mencner, and K. Komosinska-Vassev, The role of the extracellular matrix components in cutaneous wound healing. Biomed Res Int, 2014. 2014: p. 747584.
3. Koob, T.J., et al., Properties of dehydrated human amnion/chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater, 2014. 102(6): p. 1353-62.
4. Li, H., et al., Immunosuppressive factors secreted by human amniotic epithelial cells. Invest Ophthalmol Vis Sci, 2005. 46(3): p. 900-7.
5. Chatterjee, D., et al., Role of gamma-secretase in human umbilical-cord derived mesenchymal stem cell mediated suppression of NK cell cytotoxicity. Cell Commun Signal, 2014. 12: p. 63.
6. Nyman, E., et al., Hyaluronic acid, an important factor in the wound healing properties of amniotic fluid: in vitro studies of re-epithelialisation in human skin wounds. J Plast Surg Hand Surg, 2013. 47(2): p. 89-92.
7. Shanbhag, S.S., J. Chodosh, and H.N. Saeed, Sutureless amniotic membrane transplantation with cyanoacrylate glue for acute Stevens-Johnson syndrome/toxic epidermal necrolysis. Ocul Surf, 2019. 17(3): p. 560-564.
8. Rizzo, S., et al., Management of Optic Disk Pit-associated Macular Detachment with Human Amniotic Membrane Patch. Retina, 2020.
9. Shanbhag, S.S., et al., Long-term outcomes of amniotic membrane treatment in acute Stevens-Johnson syndrome/toxic epidermal necrolysis. Ocul Surf, 2020.
10. Miller, D.D., et al., Recurrent corneal erosion: a comprehensive review. Clin Ophthalmol, 2019. 13: p. 325-335.
11. Mead, O.G., S. Tighe, and S.C.G. Tseng, Amniotic membrane transplantation for managing dry eye and neurotrophic keratitis. Taiwan J Ophthalmol, 2020. 10(1): p. 13-21.