Style B 42 by 48 wide

1
Efficacy Results for VIASOL A New Media
Developed for Endothelial Cell Viability and
Cornea Preservation D.B. Soll M.D., F.A.C.S,
Inez Ruiz-White Ph.D, Tessie Smith, M.S Cleo
Cosmetics and Pharmaceuticals LLC Disclosure
VIASOL is not approved by the U.S. Food and Drug
Administration (FDA) for use however FDA review
is pending. Surgical Specialties Corp., Reading,
Pa. funded this project thru Cleo Cosmetic and
Pharmaceutical Co.   David B Soll, MD is
President of Cleo Cosmetic and Pharmaceuticals,
LLC and has a financial interest in this product
(Code R). Tessie Smith provides consulting
services to Cleo Cosmetic and Pharmaceutical, LLC
(Code E). Dr. Ruiz-White is an employee of Cleo
Cosmetic and Pharmaceuticals, LLC
2
Introduction

• Approximately 46,000 corneal grafts occur in the
  United States each year1.
• Since the importance of corneal endothelial
  cells to normal corneal function and transparency
  have been clearly established2 the aim of any
  corneal preservation technique is to preserve the
  living viable state of corneal endothelial cells
  during the storage period between donation and
  transplantation.
• The aim of this study was to determine the
  efficacy of VIASOL, a new corneal storage media,
  to preserve corneal tissue at 4?C and to compare
  the efficacy of VIASOL to the efficacy of
  Optisol-GS, the standard corneal storage media
  used by Eye Banks.
• The ability to preserve the tissue was
  determined by endothelial cell density
  measurements, cell viability, and corneal
  deturgesensce.
• References
• National Eye Institute. (2/2006). Facts About The
  Cornea and Corneal Disease. NEI. Available
  http//www.nei.nih.gov/health/cornealdisease/
• 2. Stocker, FW. The endothelium of the cornea
  and its clinical implications. Trans Am
  Ophthalmol Soc. 51669-789. 1953

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Methods
Cell Culture Assays Bovine corneal endothelial
(BCE) cells were seeded and cultured in
supplemented DMEM at 37?C. Upon confluency the
DMEM media was exchanged for either VIASOL or
Optisol-GS media and stored at 4?C for up to 14
days. MTT assays were performed at 3, 7 and 14
days (ngt5). MTT assays measures mitochondrial
respiration and is directly correlated to cell
viability. Ex-Vivo Corneal Tissue Assay 15
freshly enucleated porcine corneas were stored in
VIASOL or Optisol-GS media at 4?C. Endothelial
cell density, polymegethism, and pleomorphism
were performed by specular microscopy at day 2,
4, 7, and day 14. Corneal thickness was
determined by the pachymeter component of the
specular microscope. Viability of corneal
endothelial cells were determined by sequential
AV49 and alizarin red cells staining. AV49
stains damaged, non viable cells and alizarin red
allows visualization of cell borders.
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Results
Endothelial Cell Density The endothelial cell
density for corneal tissue stored in VIASOL after
7 and 14 days is 3511 ? 358 and 3758 ? 369
cells/mm2 respectively. The cell density for
Optisol-GS after 7 and 14 days is 2855 ? 316 and
2810 ? 440 cells/mm2 respectively. Results are
statistically significant as determined by a
paired Students T-Test. Cell Viability of
Endothelial Cells The T50, the time at which 50
of the cells remain viable, for VIASOL is 7 days.
The T50 for Optisol is 4 days. Results are
statistically significant as determined by a
paired Students T-Test.
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Results
Cell Viability of Corneal Tissue Based on cell
staining, 54 ? 12 of corneal endothelium is
damaged after 14 days in storage with Optisol-GS.
32 ? 11 of corneal endothelium is damaged after
14 days in storage with VIASOL. Initial damage
at time 0 is ? 2. Results are statistically
significant as determined by a paired Students
T-Test.
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Results
Polymegethism VIASOL results in ? 1.2 and 1.39
fold decrease in polymegethism at day 7 and day
14, respectively vs. Optisol-GS. Results are
statistically significant as determined by a
paired Students T-Test. Corneal Thickness and
Pleomorphism VIASOL and Optisol can inhibit
corneal swelling up to 7 days in storage. The
ability of VIASOL and Optisol-GS to maintain the
hexagonal shape of the corneal endothelial cells
is equivalent.
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Conclusion

• The cell viability of BCE-cells is higher when
  cultured in VIASOL vs. Optisol-GS.
• VIASOL extends the T50 of BCE cells by 3 days
  over Optisol-GS.
• At day 7 and day 14 of cell density
  measurements, VIASOL reduces endothelial cell
  loss by 24 and 34 respectively, compared to
  Optisol-GS.
• VIASOL reduces corneal damage by 40 compared to
  Optisol-GS after 14 days in storage.
• Human cornea studies are currently in progress.

8
Efficacy Results for VIASOL A New Media
Developed for Endothelial Cell Viability and
Cornea Preservation D.B. Soll M.D., F.A.C.S, Inez
Ruiz-White Ph.D, Tessie Smith, M.S Cleo Cosmetics
and Pharmaceuticals LLC
Introduction
Results
Endothelial Cell Density The endothelial cell
density for corneal tissue stored in VIASOL after
7 and 14 days is 3511 ? 358 and 3758 ? 369
cells/mm2 respectively. The cell density for
Optisol-GS after 7 and 14 days is 2855 ? 316 and
2810 ? 440 cells/mm2 respectively. Results are
statistically significant as determined by a
paired Students T-Test. Cell Viability of
Endothelial Cells The T50, the time at which 50
of the cells remain viable, for VIASOL is 7 days.
The T50 for Optisol is 4 days. Results are
statistically significant as determined by a
paired Students T-Test. Cell Viability of
Corneal Tissue Based on cell staining, 54 ? 12
of corneal endothelium is damaged after 14 days
in storage with Optisol-GS. 32 ? 11 of corneal
endothelium is damaged after 14 days in storage
with VIASOL.. Initial damage at time 0 is ?
2. Results are statistically significant as
determined by a paired Students
T-Test. Polymegethism VIASOL results in ? 1.2 and
1.39 fold decrease in polymegethism at day 7 and
day 14, respectively vs. Optisol-GS. Results are
statistically significant as determined by a
paired Students T-Test. Corneal Thickness and
Pleomorphism VIASOL and Optisol can inhibit
corneal swelling up to 7 days in storage. The
ability of VIASOL and Optisol-GS to maintain the
hexagonal shape of the corneal endothelial cells
is equivalent.
Approximately 46,000 corneal grafts occur in the
United States each year1. Since the importance
of corneal endothelial cells to normal corneal
function and transparency have been clearly
established2 the aim of any corneal preservation
technique is to preserve the living viable state
of corneal endothelial cells during the storage
period between donation and transplantation.
The aim of this study was to determine the
efficacy of VIASOL, a new corneal storage media,
to preserve corneal tissue at 4?C and to compare
the efficacy of VIASOL to the efficacy of
Optisol-GS, the standard corneal storage media
used by Eye Banks. The ability to preserve the
tissue was determined by endothelial cell density
measurements, cell viability, and corneal
deturgesensce.
Methods
Cell Culture Assays Bovine corneal endothelial
(BCE) cells were seeded and cultured in
supplemented DMEM at 37?C. Upon confluency the
DMEM media was exchanged for either VIASOL or
Optisol-GS media and stored at 4?C for up to 14
days. MTT assays were performed at 3, 7 and 14
days (ngt5). MTT assays measures mitochondrial
respiration and is directly correlated to cell
viability. Ex-Vivo Corneal Tissue Assay 15
freshly enucleated porcine corneas were stored in
VIASOL or Optisol-GS media at 4?C. Endothelial
cell density, polymegethism, and pleomorphism
were performed by specular microscopy at day 2,
4, 7, and day 14. Corneal thickness was
determined by the pachymeter component of the
specular microscope. Viability of corneal
endothelial cells were determined by sequential
AV49 and alizarin red cells staining. AV49
stains damaged, non viable cells and alizarin red
allow visualization of cell borders.
Conclusion
The cell viability of BCE-cells is higher in
VIASOL vs. Optisol-GS. VIASOL also extends
the T50 of BCE cells by 3 days over Optisol-GS.
At day 7 and day 14 of cell density
measurements, VIASOL reduces endothelial cell
loss by 24 and 34 respectively, compared to
Optisol-GS. VIASOL reduces corneal damage by 40
compared to Optisol-GS after 14 days in storage.
Human cornea studies are currently n progress.
References and Disclosures
Disclosure VIASOL is not approved by the U.S.
Food and Drug Administration (FDA) for use
however FDA review is pending. Surgical
Specialties Corp., Reading, Pa. funded this
project thru Cleo Cosmetic and Pharmaceutical Co.
  David B Soll, MD is President of Cleo Cosmetic
and Pharmaceuticals, LLC and has a financial
interest in this product (Code R). Tessie Smith
provides consulting services to Cleo Cosmetic and
Pharmaceutical, LLC (Code E). Dr. Ruiz-White is
an employee of Cleo Cosmetic and Pharmaceuticals,
LLC References 1. National Eye Institute.
(2/2006). Facts About The Cornea and Corneal
Disease. NEI. Available http//www.nei.nih.gov/h
ealth/cornealdisease/ 2. Stocker, FW. The
endothelium of the cornea and its clinical
implications. Trans Am Ophthalmol Soc.
51669-789. 1953