Download Cytotoxicity Potential of Ganfort® UD in Cultured Human Corneal

CYTOTOXICITY POTENTIAL OF GANFORT
EPITHELIAL CELLS
J. Shen, W. Chang
UD IN CULTURED HUMAN CORNEAL
Pharmacokinetics and Drug Disposition, Allergan, USA
Purpose: The assessment of ocular surface toxicity is crucial for the development of topical
ophthalmic medications. We evaluated the cytotoxicity potential of the topical glaucoma
medication Ganfort UD on corneal epithelial cells. Methods: Human corneal epithelial cells
were grown on filters. Ganfort UD was applied to the apical side of the cell layers, while
growth medium bathed the cells from the basolateral side. In similar fashion, phosphate
buffered saline (PBS) was applied as a negative control, and PBS containing 0.01%, 0.02%,
and 0.03% benzalkonium chloride (BAK) was applied to establish dose response under the
same experimental condition. Following 16-hour incubation, cell viability was determined for
all treatment arms (n=3 per arm) using the standard MTT assay. All samples were analyzed
by spectrophotometry. Percent viability relative to saline treatment was calculated using the
optical density values obtained for each treatment arm. Results: Dose-dependent increase in
cytotoxicity was observed at BAK concentrations of 0.01%, 0.02%, and 0.03%, with 97.5% (p
= 0.503), 77.1% (p0.05), and 29.5% (p0.05) cell viability relative to the saline control. Cells
incubated with Ganfort UD had 119±7% (p0.05) cell viability relative to the PBS control.
Conclusion: Ganfort UD showed no potential of cytotoxicity on culture human corneal
epithelial cells, as expected for a formulation containing no preservative. This result is in
contrast to prior, similar research showing cytotoxicity of formulations containing BAK,
Polyquad (polyquauternium-1), and sofZia. Further research will be conducted using this
model to compare Ganfort UD directly against formulations containing Polyquad and
sofZia.