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Sci Rep. 2018 Jul 12;8(1):10500. doi: 10.1038/s41598-018-28861-5.

RGN-259 (thymosin β4) improves clinically important dry eye efficacies in comparison with prescription drugs in a dry eye model.

Author information

1
Department of Ophthalmology, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, 47392, Korea.
2
Department of Biochemistry and Molecular Biology, The George Washington University School of Medicine, Washington D.C, USA.
3
ReGenTree, LLC, 116 Village Boulevard, Suite 200, Princeton, NJ, USA.
4
Departments of Ophthalmology and Anatomy/Cell Biology, Kresge Eye Institute, Wayne State University School of Medicine, Detroit, Michigan, USA.
5
Ora. Inc., 300 Brickstone Square, Andover, MA, USA.
6
Department of Pharmaceutical Engineering, Inje University, Gimhae, Republic of Korea.
7
Department of Ophthalmology, Inje University College of Medicine, Inje University Busan Paik Hospital, Busan, 47392, Korea. oculoplasty@gmail.com.
8
T2B infrastructure Center for Ocular Disease, Inje University Busan Paik Hospital, Busan, 47392, Korea. oculoplasty@gmail.com.

Abstract

This study evaluated the clinical activity of RGN-259 (thymosin β4) in comparison with cyclosporine A (CsA), diquafosol (DQS), and lifitegrast (LFA) in a murine model of dry eye. The model was NOD.B10-H2b mice in a 30-40% humidified environment together with daily scopolamine hydrobromide injections for 10 days. After desiccation stress, all drugs were evaluated after 10 treatment days. RGN-259 increased tear production similar to that in the DQS- and LFA-treated mice while CsA was inactive. RGN-259 improved corneal smoothness and decreased fluorescein staining similar to that of LFA group while CsA and DQS were inactive. Corneal epithelial detachment was reduced by RGN-259, and DQS and LFA showed similar activity but the CsA was inactive. RGN-259 increased conjunctival goblet cells and mucin production comparable to that seen with CsA, while DQS and LFA were inactive. RGN-259 reduced the over-expression of inflammatory factors comparable to that with CsA and LFA, while DQS was inactive. RGN-259 increased mucin production comparable to that observed with CsA, while DQS and LFA were inactive. In conclusion, RGN-259 promoted recovery of mucins and goblet cells, improved corneal integrity, and reduced inflammation in a dry eye mouse model and was equal to or more effective than prescription treatments.

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