April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Effects of Thymosin β4 in a Murine CAETM Model of Experimental Dry Eye
Author Affiliations & Notes
  • Christian B. Allan
    R & D,
    RegeneRx Biopharmaceuticals, Inc., Rockville, Maryland
  • David Crockford
    Clinical and Regulatory,
    RegeneRx Biopharmaceuticals, Inc., Rockville, Maryland
  • Kathryn S. Crawford
    Pre-Clinical Development, Ora, Inc., Andover, Massachusetts
  • Laura J. Belen
    Pre-Clinical Development, Ora, Inc., Andover, Massachusetts
  • Footnotes
    Commercial Relationships  Christian B. Allan, RegeneRx Biopharmaceuticals, Inc. (E); David Crockford, RegeneRx Biopharmaceuticals, Inc. (E); Kathryn S. Crawford, Ora, Inc. (E); Laura J. Belen, Ora, Inc. (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 3782. doi:
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    • Get Citation

      Christian B. Allan, David Crockford, Kathryn S. Crawford, Laura J. Belen; Effects of Thymosin β4 in a Murine CAETM Model of Experimental Dry Eye. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3782.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : The purpose of this study was to investigate the potential of Thymosin β4 (RGN-259) to ameliorate the signs of dry eye syndrome (DES) in a murine model.

Methods: : Topical solutions containing 2.0%, 1.0%, or 0.1% Thymosin β4 in balanced salt solution (BSS) were tested against vehicle (BSS). A positive control (doxycycline 0.005%) group and an untreated non-DES group were also included. Forty C57BL/6 mice were housed in a controlled adverse environment (CAETM) for 20 days and dosed four times daily on days 7-20. On days 15-18, mice were injected with 0.5mg/0.2ml of scopolamine hydrobromide four times a day to further exacerbate signs of DES. All mice were evaluated on days 7, 15, 18, and 20 of CAE exposure. Corneal fluorescein staining was assessed microscopically in 5 corneal regions (modified NEI scale); tear production was measured using phenol red threads (Zone-Quick).

Results: : Thymosin β4 at the lowest concentration (0.1%) effectively reduced corneal fluorescein staining. On days 15 and 18 of CAE exposure, animals treated with Thymosin β4 0.1% showed a marked and statistically significant decrease in total fluorescein staining and in specific regions compared to the vehicle control group. Staining was reduced from pre-dose levels (5.8±0.7) to baseline levels (2.0±0.8). The reduction in staining was also greater in the Thymosin β4 group (0.1%) compared to the positive control group (doxycycline). As formulated, the higher concentrations (1.0% and 2.0%) of Thymosin β4 had no impact on corneal staining. None of the treatments had any effect on tear production in this study.

Conclusions: : These results, along with other evidence demonstrating the wound healing properties of Thymosin β4, indicate that Thymosin β4 is a good candidate for a novel and effective dry eye therapy. Further investigation with additional concentrations, modifications in the formulation and different dosing regimens is warranted.

Keywords: wound healing • cornea: epithelium 
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