RegeneRx announces positive results from RGN-259 non-clinical study for Dry Eye Syndrome

RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (the "Company" or "RegeneRx") today announced the results of its first non-clinical dry eye study using RGN-259, RegeneRx's ophthalmic, preservative-free eye drop for the treatment of Dry Eye Syndrome (DES). In the study, animals were treated with RGN-259, a vehicle control and a positive control, doxycycline. Corneal fluorescein staining was used to measure the surface defects after induction of DES using an industry accepted dry eye model. In animals treated with RGN-259, a "dramatic" and statistically significant reduction in corneal staining (p<0.03) was observed compared to those treated with the vehicle control and equivalent to original levels seen prior to induction of DES. The treatment effect using RGN-259 was also more pronounced than that observed with the positive control, an accepted treatment for dry eye and ocular surface inflammation.

"These findings are very compelling because this is a standardized model widely used to advance drugs into human clinical dry eye studies and has been pivotal in determining treatment efficacy in various dry eye development programs," stated David Crockford, RegeneRx's vice president of clinical and regulatory affairs. "The fact that the study animals had a statistically significant reduction in corneal staining compared to control animals (equivalent to pre-treatment levels) is consistent with the healing effects observed in patients with non-healing corneal ulcers and with previous animal studies using RGN-259. Moreover, we believe this study further illustrates the significant commercial potential of our ophthalmic drug candidate."

Dr. Gabriel Sosne, Associate Professor of Ophthalmology at Wayne State University School of Medicine, Department of Ophthalmology and Anatomy/Cell Biology in Detroit, Michigan, added, "This study is the first direct indication that RGN-259 may be effective as a treatment for dry eye syndrome, one of the most vexing and difficult problems routinely seen by all eye care professionals. The clinical implication of these results suggests that the use of RGN-259 to treat dry eye is not only warranted but could have a major impact in the field." Dr. Sosne is a member of RegeneRx's scientific advisory board.