| RGN-259 Eye Drops | |
| N. Keratitis |  |
| GVHD Dry Eye |  |
| Diabetic Vitrectomy |  |
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RGN-259 RegeneRx is developing RGN-259, a Tβ4-based sterile eye drop, as a novel treatment for corneal healing. RGN-259 represents a new approach to corneal healing, as there is currently no pharmaceutical agent that has shown corneal repair and anti-inflammation properties. Preclinical studies have identified cell migration, anti-apoptotic and anti-inflammatory activities of Tβ4 in the cornea. RegeneRx conducted a phase 2 clinical trial of RGN-259 in diabetic patients who underwent corneal epithelial debridement during vitrectomy surgery. However, due to very slow enrollment and new clinical data generated under a "Compassionate Use" IND (see below), this phase 2 trial was closed in January 2009. RegeneRx is planning to support a physician-sponsored corneal trial in 2010 in patients with dry eye associated with graft vs. post disease (GVHD). No phase 1 ophthalmic trial was required for RGN-259 by the FDA after its assessment of our dermal phase 1 safety data and relevant preclinical data. In November of 2008, RGN-259 was used to treat neurotrophic keratitis patients with non-healing corneal ulcers under a “Compassionate Use” IND. Dr Steven Dunn, a corneal specialist, treated all four patients for 28 days with RGN-259. The eye ulcers either completely healed or demonstrated significant improvement by the 28th day of treatment. During the 30-day follow-up period patients continued to improve even though the treatment regimen had been completed. |