BIOVANCE 3L Ocular Pending Review - Verséa
 

MEETING THE CLINICAL NEEDS OF OCULAR SURFACE DISEASES

Almost 40% of patients (37.4%) undergoing cataract surgery experienced significant postoperative dry eye.¹

Both incidence and severity of dry eye symptoms increase even further after cataract surgery2. In cataract surgery, Li et al showed that dryness peaks at 1 month¹. There are many factors that might contribute to dryness post cataract surgery:2-5 BAK in drops,3 exposure to intense light,4 and corneal nerve denervation.4-5

https://www.versea.com/wp-content/uploads/2024/03/dry-eyes.png

Corneal epithelial defects are focal areas of epithelial loss most frequently caused by mechanical trauma, corneal dryness, neurotrophic keratitis, post surgical changes, or infection.10

Amniotic membrane graft applications as a cover or barrier may include, but are not limited to, corneal and conjunctival related injuries or defects such as corneal epithelial defects, pterygium repair, fornix reconstruction and other procedures.

Common diagnoses resulting in or associated with corneal defects include:

BIOVANCE® 3L OCULAR

Human Amniotic Membrane Allograft

Indications For Use

BIOVANCE 3L Ocular is an allograft intended for use as a biological membrane covering that provides an extracellular matrix. As a barrier membrane, BIOVANCE 3L Ocular is intended to protect the underlying tissue and preserve tissue plane boundaries. Applications include, but are not limited to, corneal and conjunctival related injuries or defects such as corneal epithelial defects, pterygium repair, fornix reconstruction, and other procedures.

BIOVANCE 3L Ocular is a pure human amniotic tissue with an intact basement membrane¹:

  • Devoid of cells, hormones, growth factors and cytokines
  • Retention of natural proteins (e.g. collagen, laminin, fibronectin)
  • Serves as a cell-friendly structure for cell attachment²
  • Cell attachment is a natural stimulus for the orderly release of growth factors and cytokines¹

To learn more visit our Resources page

https://www.versea.com/wp-content/uploads/2024/04/Biovance-Premium-Brochure_layer-comparison-graphic_transparent.png

Designed for Premium Handleability

Biovance® 3L Ocular is a three-layer decellularized, dehydrated, human amniotic membrane.

Cut and assembled as a unique laminated tri-layer design with the stromal side of amniotic membrane on both sides of the scaffold facing out to ensure the correct side interfaces with the ocular surface regardless of the  orientation of the scaffold.

Biovance® 3L Ocular’s three layer design enhances its handling properties, without the need for a ring.

Benchtop Study Findings

BIOVANCE 3L Ocular vs. ChAM & DhAM*

Cell attachment is a natural stimulus for the orderly release of growth factors and cytokines¹.

With its unique 3-layer amnion basement membrane construction, BIOVANCE 3L Ocular is designed for superior handling and creating an optimal matrix for cell viability, adhesion, and proliferation, providing a cell-friendly environment as demonstrated in a comparative benchtop study²’³:

  • Ocular epithelial cell viability significantly greater than ChAM and DhAM (p<0.001)²
  • Ocular epithelial cell adhesion significantly greater as compared to ChAM and DhAM (p≤0.011)²
  • Ocular epithelial cell proliferation rate significantly greater than ChAM (p<0.001)²

* ChAM=cryopreserved human amniotic membrane;  DhAM=dehydrated human amniotic membrane

https://www.versea.com/wp-content/uploads/2024/04/Biovance-Premium-Brochure_Adhesion-proliferation-graphs_Transparent.png

 

To learn more visit our Resources page

Visual Comparison of Amniotic Membrane Grafts - Day 4

Ocular epithelial cell viability with Biovance 3L Ocular is significantly greater than ChAM or DhAM at day 4.

Human corneal epitheal cells were seeded on the different scaffolds, cultured, and stained with Calcein AM to visualize viable cells at Day 4 (A). The morphology of human corneal epithelial cells on scaffolds was monitored by actin staining on Day 4 (B).

Post procedure BCVA improved in all patients with an initial BCVA less than 20/25.

Visual Comparison of Amniotic Membrane Grafts - Day 4

BCVA: Best Corrected Visual Acuity

https://www.versea.com/wp-content/uploads/2024/04/Biovance-Premium-Brochure_BVCA-Results-Graph_Transparent.png

Top 10 reasons to use Biovance 3L Ocular

  1.    Unique 3-layer design
  2.    Easy to handle
  3.    No upfront preparation
  4.    Decellularized (no donor pro-inflammatory cell debris)
  5.    Protects underlying tissue
  6.    Ringless design
  7.    Bidirectional (can be applied on either side)
  8.    Room temperature storage
  9.    10-year shelf life
  10.    Access support for patients (e.g. benefits verification)

BIOVANCE 3L Ocular is available in 6 convenient shapes & sizes

3L Ocular Clinical Application Process Video

Order Biovance 3L Ocular Now
Using our Order Form
IMPORTANT SAFETY INFORMATION

Biovance 3L Ocular is contraindicated in patients with a known hyper-sensitivity to BIOVANCE 3L Ocular. If a patient has an adverse reaction related to the use of BIOVANCE 3L Ocular, immediately discontinue its use. BIOVANCE 3L Ocular should not be used on clinically infected wounds. The pouch contents are sterile if the pouch is unopened and undamaged. Do not use if package seal is broken. Discard material if mishandling has caused possible damage or contamination. Do not resterilize. BIOVANCE 3L Ocular must be used prior to the expiration date on the product pouch. BIOVANCE 3L Ocular should not be used together with a collage-nase product on the wound.

For product information, contact 1-800-397-0670.
For adverse reaction reporting, contact 1-844-963-2273.
Please refer to the Biovance 3L Ocular package insert for complete product information.

1. Bhatia M, Pereira M, Rana H, Stout B, Lewis C, Abramson S. The mechanism of cell interaction and response on decellularized human amniotic membrane: Implications in wound healing. 2007;19(8):207-217.
2. Diaz V. et al; ARVO2022 Poster; A Comparison Study of the Effects of Ocular Scaffolds on Human Ocular Epithelial Cells.
3. Mao Y, Protzman NM, John N, et al. An in vitro comparison of human corneal epithelial cell activity and inflammatory response on differently designed ocular amniotic membranes and a clinical case study. J Biomed Mater Res. 2022;1‐17. doi:10.1002/jbm.b.35186”

BIOVANCE® is a registered trademark of Celularity Inc. Verséa is a trademark of Verséa Health, Inc.

©2024 Versea Ophthalmics, Inc. All rights reserved.

https://www.versea.com/wp-content/uploads/2024/03/Versea-Ophthamics_wordmark_icon_white.png

If you would like to learn more about Biovance 3L Ocular, please contact us at ophthalmics@versea.com