Results of the 72-patient, placebo-controlled Phase II study evaluating RGN-259 (RegeneRx preservative-free eye drops) for the treatment of dry eye patients using Ora Inc.'s controlled adverse environment (CAE) model have been published and identify the key efficacy targets for a larger, multi-center, Phase IIb/III U.S. clinical trial targeted for later this year. The trial will be sponsored by ReGenTree, LLC, a U.S. joint venture owned by RegeneRx and G-treeBNT.
In the study, a number of important outcome measures, including central, superior, and peripheral corneal staining demonstrated statistically significant improvements in the RGN-259-treated group compared to placebo (p=0.0075, p=0.0210 and p=0.0379, respectively). RGN-259 also reduced exacerbation of ocular discomfort after CAE® challenge (p=0.0224). The drug candidate was well-tolerated and there were no observed adverse side effects. As previously reported, the co-primary outcome measures, inferior corneal staining and patient ocular discomfort 24 hours after CAE® challenge, did not show statistically significant differences.
"We are quite excited to have identified significant improvements in both signs and symptoms of dry eye, which have since been confirmed in subsequent studies. Not only have we identified FDA-approvable sign and symptom endpoints that will be the target of U.S. dry eye trials later this year, we also saw the potential for RGN-259 as a preventative modality for patients prone to dry eye syndrome as evidenced by their improvements after challenge in a controlled adverse environment. Additionally, the statistically significant improvements in central corneal staining at 24 hours post-CAE® are consistent with the acceleration of healing seen in other patients treated with RGN-259. We look forward to the larger, more robust study that is expected to begin later this year," stated Dr. Gabriel Sosne, Associate Professor, Department of Ophthalmology and Anatomy/Cell Biology, Wayne State University School of Medicine Kresge Eye Institute, Detroit, Michigan, and one of the authors of the paper. Dr. Sosne is a member of RegeneRx's Scientific Advisory Board.
Citation: Gabriel Sosne, George Ousler,"Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model," Clinical Ophthalmology, May 2015; Vol. 2015:9, 877-884.