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George W Ousler, Joseph B Ciolino, Won S. Yang, Gabriel Sosne; Safety and Efficacy of 0.05% and 0.1% RGN-259 for Subjects with Dry Eye Syndrome (DES): ARISE I. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2668.
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© ARVO (1962-2015); The Authors (2016-present)
RGN-259, or thymosin beta 4, is a ubiquitous low molecular weight protein that promotes cell migration and wound healing and has anti-inflammatory properties. This phase 2b/3 clinical study evaluated the safety and efficacy of RGN-259 for the treatment of dry eye.
This multi-center, randomized, double-masked, placebo-controlled clinical trial assessed the safety and efficacy of 0.05% and 0.1% RGN-259 for DES using the Controlled Adverse Environment (CAE®) model. 317 subjects were randomized in a 1:1:1 ratio to receive 0.05%, 0.1% RGN-259 or placebo ophthalmic solution bilaterally, four times per day for 28 days. The study comprised of 5 visits over 5 weeks. The primary efficacy endpoints were change from Pre-CAE to Post-CAE in the total corneal fluorescein staining score on the Ora Calibra® scale at Visit 5 for the sign, and change from Pre-CAE to Post-CAE in ocular discomfort score on the Ora Calibra® Ocular Discomfort Scale at Visit 5 for the symptom.
After 28 days of treatment, 0.1% RGN-259 significantly reduced ocular discomfort during CAE exposure compared to placebo (ITT, p=0.043). Ocular discomfort after CAE exposure was also significantly improved on Day 28 in the 0.05% and 0.1% RGN-259 over placebo (ITT, p=0.0366 and p=0.0072), indicating a dose-dependent response. Furthermore, in patients who were more symptomatic at baseline, ocular discomfort prior to CAE exposure was significantly improved in the 0.05% and 0.1% RGN-259 groups (p=0.022 and p=0.006, vs. placebo, respectively). RGN-259 also improved ocular surface staining after 28 days of dosing in patients with compromised tear film break-up time at baseline. At Visit 5, these subjects in both the 0.05% and 0.1% RGN-259 group had significantly reduced total corneal staining (p = 0.0310, p = 0.0274, respectively) and inferior corneal staining (p = 0.0171, p = 0.0062, respectively) pre-CAE (change from baseline) over placebo. There were no significant drug-related adverse or serious adverse events and RGN-259 was well-tolerated and comfortable for the patients with no irritation upon instillation.
These data indicate that RGN-259 has a fast-acting treatment effect on both the signs and symptoms of dry eye disease, confirming positive results of the Phase 2a study.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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