RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced that its US joint venture with G-treeBNT, ReGenTree LLC, has completed enrollment of its phase 2b/3 dry eye trial in the US. The trial is testing RGN-259 (Thymosin beta 4), a sterile, preservative-free eye drop developed for patients with dry eye syndrome, neurotrophic keratopathy (NK), and other corneal disorders.
The co-primary endpoints are assessments of total corneal staining and reduction of ocular discomfort in patients using RGN-259 compared to those using placebo. Patients will use the eye drops 4 times daily for 28 days and be assessed periodically throughout the trial and at completion of treatment. There will be numerous secondary endpoints that will also be evaluated pursuant to the trial protocol.
"Completion of enrollment for the dry eye study marks a key milestone. Treatment and patient follow-up should be completed in February with data analysis shortly thereafter. Everyone involved in the study is looking forward to the efficacy analysis and toward commercial development of RGN-259 for this underserved market. Positive results should also have a significant impact in the development cycle for our product candidate in Asia, Europe, and other markets throughout the world, as well as in its development for other ocular indications," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.