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Thymosin β4 Significantly Improves Signs and Symptoms of Severe Dry Eye in a Phase 2 Randomized Trial

Sosne, Gabriel MD; Dunn, Steven P. MD; Kim, Chaesik BSEE

doi: 10.1097/ICO.0000000000000379
Clinical Science
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Purpose: Standard therapies for severe dry eye are limited and fail to resolve the problem. The purpose of this study was to evaluate the safety and efficacy of Thymosin β4 eye drops (RGN-259) as a novel therapy for severe dry eye disease (including that associated with graft vs. host disease).

Methods: A small, multicenter, randomized, double-masked, placebo-controlled 56-day phase 2 clinical trial including a 28-day follow-up at 2 US sites. Nine patients with severe dry eye were treated with either RGN-259 (0.1%) or vehicle control 6 times daily over a period of 28 days. Dry eye sign and symptom assessments, such as ocular discomfort (using the OSDI questionnaire) and corneal fluorescein staining (using the NEI workshop grading system), were evaluated at various time points.

Results: Statistically significant differences in both symptom and sign assessments, were seen at various time points throughout the study. Of particular note at day 56, the RGN-259–treated group (12 eyes) had 35.1% reduction of ocular discomfort compared with vehicle control (6 eyes) (P = 0.0141), and 59.1% reduction of total corneal fluorescein staining compared with vehicle control (P = 0.0108). Other improvements seen in the RGN-259–treated patients included tear film breakup time and increased tear volume production.

Conclusions: In this small trial, RGN-259 eye drops were safe and well tolerated and met key efficacy objectives with statistically significant symptom and sign improvements, compared with vehicle control, at various time intervals, including 28-days posttreatment.

Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01393132.

Departments of *Ophthalmology, and

Anatomy and Cell Biology, Kresge Eye Institute, Wayne State University, School of Medicine, Detroit, MI;

Michigan Cornea Consultants, Southfield, MI; and

§Kresge Eye Institute, Detroit, MI.

Reprints: Gabriel Sosne, MD, Departments of Ophthalmology and Anatomy and Cell Biology, Kresge Eye Institute, Wayne State University School of Medicine, 4717 St Antoine, Detroit, MI 48201 (e-mail: gsosne@med.wayne.edu).

Supported by RegeneRx Biopharmaceuticals Inc.

G. Sosne is on the Medical Advisory Board of RegeneRx Biopharmaceuticals Inc and occasionally provides intellectual advice. This company is developing RGN-259 for clinical treatment of wounds, including dry eye. The remaining authors have no funding or conflicts of interest to disclose.

Received September 30, 2014

Received in revised form December 18, 2014

Accepted December 18, 2014

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.