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 both tissue 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 II 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 II trial was closed in January 2009. RegeneRx is planning to initiate a new corneal trial in late 2009 or early 2010 in a more commercially viable indication.

No phase I ophthalmic trial was required for RGN-259 by the FDA after its assessment of our dermal phase I safety data and relevant preclinical data.

	Corneal Wounds (CLOSED) Recurrent Corneal Erosions Corneal Surgeries Sjögren’s Dry Eye

In 2006, the FDA granted a “Compassionate Use” IND for a diabetic vitrectomy patient at Wayne State University Medical Center. This patient’s cornea failed to heal 23 days after surgery. RGN-259 was applied for 11 days and produced a measureable reduction in inflammation and irritation around the eye and corneal healing by day 11 of the treatment (Figure 1).

Figure 1. Click to enlarge

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 28^th day of treatment. During the 30-day follow-up period patients continued to improve even though the treatment regimen had been completed.