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BioDOPTIX® amniotic extracellular matrix is a dehydrated, membrane allograft derived from human amniotic tissue that is intended for use in ocular tissue repair.

BioDOPTIX®

A M N I O T I C E X T R A C E L L U L A R M A T R I X

Human amniotic membrane has been used to treat a variety of wounds for over 100 years and the first reported use for ocular surface defects was reported in 1940 by De Roth.1-3 Research has shown that placental tissues can promote new tissue formation, reduce scar tissue formation, modulate inflammation and pain and may have anti-microbial effects.3-15

The amnion membrane is composed of:

• Collagen, elastin, fibronectin and proteoglycans that provide a three-dimensional architecture to promote reconstruction of damaged tissue.

• Growth factors, such as PDGF, VEGF, TGF-ß, FGF and IGF, as well as other proteins, anti-inflammatory cytokines and peptides that promote tissue repair.

Retains the structure of unprocessed human amniotic membrane including extracellular matrix (ECM)

Laboratory analyses and assays demonstrated that DryFlex®

processing preserves continuous, intact epithelium, basement

membrane, compact and fibroblast layers of the amniotic

tissue, as illustrated in the histology section on the right.16

Other histological assessments demonstrated the presence

of collagen and proteoglycans.16

Retains key proteins of unprocessed human amniotic membrane

Laboratory analyses and assays demonstrated that the presence of cytokines and growth factors were maintained with

particularly high quantities of EGF, PDGF, TGF-ß, and TIMPs 1 and 2.16

Why Amniotic Tissue?

The science behind DryFlex® processing of human placental tissues

Epithelium

Basement Membrane

Compact Layer

Fibroblast Layer

Spongy Layer

STRUCTURE OF THE AMNIOTIC MEMBRANE

Hematoxylin and Eosin (H&E) stained tissue demonstrating normal amnion architecture with intact epithelium, compact layer and fibroblast layer.

Histology of BioDOptix® (Magnified image of BioDOptix Amniotic Extracellular Matrix)

Amnion epithelial cells

Fibroblast layer Compact

layer

BioDOptix Native human amnionInterleukins

IL-4 + +

IL-6 + +

IL-8 + +

IL10 + +

Tissue Inhibitors of MetalloproteasesTIMP-1 + +

TIMP-2 + +

TIMP-4 + +

BioDOptix Native human amnionGrowth Factors

bFGF + +

EGF + +

G-CSF + +

PDGF-AA + +

PDGF-BB + +

PLGF + +

TGF-ß + +

TGF-ß1 + +

BioDOPTIX®

A M N I O T I C E X T R A C E L L U L A R M A T R I X

BioDOptix Membrane Case Study

Introduction: Filamentary Keratitis is a painful condition in which strands (“filaments”) composed of degenerated epithelial cells and mucous develop on the surface of the cornea. Blinking causes pain due to eyelid traction of these filaments on the highly innervated cornea. Frequent symptoms are foreign body sensation, light sensitivity and blepharospasm. The classic clinical exam finding is the presence of these filaments on the surface of the cornea which are most easily seen with fluorescein staining. Common predisposing conditions include aqueous deficient dry eye, superior limbic keratitis, corneal exposure, edema, or surgery and contact lens wear. 

Patient History: The patient is a 65 year old female who underwent radial keratotomy surgery over two decades ago. She subsequently had photorefractive keratectomy to correct consecutive hyperopia following the radial keratotomy.

Initial Assessment and Treatment Strategy: On the initial exam, the patient already had signs and symptoms of dry eye, including foreign body sensation and punctate epithelial erosions.

Treatment Strategy: The patient was treated with traditional therapy including artificial tears, cyclosporine eye drops and lower lid punctual plugs in addition to pulsed episodes of steroid eye drops to decrease inflammation. Despite these therapeutic interventions, the patient began to develop episodes of filamentary keratitis in her left eye. This was managed with removal of the filaments under topical anesthesia and more aggressive management of the dry eye including punctal plugs to the upper lids, increased frequency of the artificial tears, lid hygiene with warm compresses and flaxseed oil by mouth. When these interventions failed to halt the progress of her filamentary keratitis (Figure 1), a 12mm BioDOptix amniotic membrane disc was placed in the affected eye.

For the procedure, the patient was taken to the minor room. After confirming the eye to be treated, one drop of Proparacaine was given and a sterile lid speculum was carefully placed. Under the operating microscope, the BioDOptix membrane was placed on the indicated eye, ensuring the correct orientation. Eye spears were used to flatten and center the BioDOptix membrane. A bandage contact lens was then placed on the eye and the lid speculum removed. The patient tolerated the procedure well.

Outcomes: The patient experienced instant relief with our standard protocol for amniotic membrane placement and noted at her 1 week visit that her “eye feels great”. This was after numerous bouts of discomfort from the filaments and subsequent keratitis. At follow-up visits at both two weeks and one month, she remained asymptomatic and no filaments were detected (Figure 2 and 3).

Case provided by Christopher Blanton, MDInland Eye InstituteColton, CA

BEFORE

Figure 1

2 WEEKS FOLLOWUP

Figure 2

1 MONTH FOLLOWUP

Figure 3

Filamentary Keratitis

PERFORMANCE• Dehydrated using our proprietary DryFlex® process that preserves the inherent ECM,

growth factors, and cytokines of the amniotic tissue• Easy to apply and conforms well to the anterior ocular surface• Placement generally does not require sutures or glue

CONVENIENCE• Circular or rectangular sizes for appropriate fit• Dehydrated product allows for easy trim-to-size fitting• Room temperature storage with 5 year shelf life• Convenient for use in inpatient, outpatient or clinic settings

CONFIDENCE• Amniotic tissues have been described as immune-privileged because they rarely evoke an immune

response in the human body17

• Tissue recovered from live, healthy donors during cesarean childbirth• Donor selection, tissue recovery and processing protocols and procedures meet or exceed all applicable

industry standards to ensure patient safety

Common Clinical Applications of Amniotic Tissues

• Epithelial Basement Membrane Dystrophy

• Keratitis

• Corneal Ulcer

• Recurrent Corneal Erosion

• Persistent Epithelial Defect

• Pterygium

• Band Keratopathy

• Bullous Keratopathy

BioDOptix

PRODUCT ID SIZE

OX-010152 1.5 x 2.0cm2

OX-010203 2.0 x 3.0cm2

OX-010009 9.0mm disc

OX-010012 12.0mm disc

OX-010015 15.0mm disc

BioDOptix is regulated by the FDA under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

References: 1. Davis JW. Skin Transplantation. Johns Hopkins Med J 1910;15:307–96. 2. De Roth A. Plastic repair of conjunctival defects with fetal membranes. Arch Ophthalmol. 1940; 23: 522-5. 3. Hao Y, Ma DH, Hwang DG, et al. Identification of antiangiogenic and anti-inflammatory proteins in human amniotic membrane. Cornea 2000;19(3):348–52. 4. Fetterolf DE, Snyder RJ. Scientific and clinical support for the use of dehydrated amniotic membrane in wound management. Wounds 2012(10):299–307. 5. Solomon A. Suppression of interleukin 1alpha and interleukin 1beta in human limbal epithelial cells cultured on the amniotic membrane stromal matrix. Br J Ophthalmol 2001;85(4):444–9. 6. Kim JS, Kim JC, Na BK, et al. Amniotic membrane patching promotes healing and inhibits proteinase activity on wound healing following acute corneal alkali burn. Exp Eye Res 2000;70(3):329–37. 7. Tseng SCG, Li D-Q, Ma X. Suppression of transforming growth factor‐beta isoforms, TGF‐ß receptor type II, and myofibroblast differentiation in cultured human corneal and limbal fibroblasts by amniotic membrane matrix. J Cell Physiol 1999;179(3):325–35. 8. Lee S-B, Li D-Q, Tan DT, et al. Suppression of TGF-ß signaling in both normal conjunctival fibroblasts and pterygial body fibroblasts by amniotic membrane. Curr Eye Res 2000;20(4):325–34. 9. Adzick NS, Longaker MT. Scarless fetal healing: Therapeutic implications. Ann Surg 1992;215(1):3–7. 10. Cuttle L, Nataatmadja M, Fraser JF, et al. Collagen in the scarless fetal skin wound: Detection with Picrosirius-polarization. Wound Repair Regen 2005;13(2):198–204. 11. Aagaard-Tillery KM, Silver R, Dalton J. Immunology of normal pregnancy. Semin Fetal Neonatal Med 2006;11(5):279–95. 12. Chen EH, Tofe AJ. A literature review of the safety and biocompatibility of amnion tissue. J Impl Adv Clin Dent 2010;2(3):67–75. 13. Bailo M, Soncini M, Vertua E, et al. Engraftment potential of human amnion and chorion cells derived from term placenta. Transplantation 2004;78(10):1439–48. 14. Liu J, Sheha H, Fu Y, et al. Update on amniotic membrane transplantation. Expert Rev Ophthalmol 2010;5(5):645–61. 15 . Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev 2003;83(3):835–70. 16. Data on file. 17. Kubo, et al. Immunogenicity of Human Amniotic Membrane in Experimental Xenotransplantation. Investigative Ophthalmology & Visual Science, June 2001, Vol. 42, No. 7.

BioDOPTIX®

A M N I O T I C E X T R A C E L L U L A R M A T R I X

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