RegeneRx Biopharmaceuticals announced that a new study was published comparing RGN-259 with currently approved prescription products for dry eye syndrome (DES). In the study, researchers demonstrated that after 10 days of treatment RGN-259 performed equal to or better than cyclosporine A (Restasis), lifitegrast (Xiidra), and diquafosol (Diquas). The study parameters measured were tear production, corneal smoothness, and decreased fluorescein staining, among others. Corneal epithelial detachment, conjunctival goblet cells, mucin production, and expression of inflammatory factors were also evaluated. RGN-259 was equal to or better than the three other approved products in each case, according to a company news release. In conclusion, the authors stated that, “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.”
The study was published on July 12, 2018, in the journal, Scientific Reports, an online open access scientific mega journal and part of the Nature Publishing Group. The study was conducted by researchers who are either consultants to RegeneRx or, employees of, or consultants to GtreeBNT/ReGenTree LLC, a RegeneRx licensee for RGN-259 in North American and certain Asian territories. Some of the study data were previously presented at the 2018 ARVO meeting in May 2018.
RGN-259 is currently in phase 3 clinical trials in the U.S. and been studied in approximately 1,000 patients. In addition to the reported rapid onset of clinical efficacies, RGN-259 has not reported any significant side effects compared to other products currently approved for DES.