RegeneRx Biopharmaceuticals has announced preliminary results from its Phase 2 trial evaluating RGN-259 (Tß4 preservative-free eye drops) for the treatment of severe dry eyes.

The double-masked, physician-sponsored study treated nine patients with severe dry eyes (18 eyes) with RGN-259 or vehicle control six times daily over a period of 28 days.

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Compared to vehicle control, at various time intervals, including 28 days post-treatment, RGN-259 met key efficacy objectives with statistically significant sign and symptom improvements and was found to be safe and well-tolerated.

"The fact that the study achieved statistically significant clinical differences between RGN-259 and vehicle control in key ocular assessments in the small number of patients is encouraging."

RegeneRx scientific advisory board member, Wayne State University and the Kresge Eye Institute ophthalmologist, Gabriel Sosne, said the fact that the study achieved statistically significant clinical differences between RGN-259 and vehicle control in key ocular assessments in the small number of patients is encouraging.

"Moreover, these patients had severe dry eye, three of whom suffered from graft versus host disease, giving us some confidence that we may see a positive effect in various types of dry eye patients," Sosne added.

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Statistically significant differences in sign and symptom assessments, including ocular discomfort and corneal fluorescein staining, were observed at different time points throughout the vehicle-controlled study.

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A 35.1% reduction of ocular discomfort compared to vehicle control and a 59.1% reduction of total corneal fluorescein staining compared to vehicle control were reported in RGN-259-treated group.

Tear film breakup time and increased tear volume production were other improvements observed in the RGN-259-treated patients.

Allan Goldstein, RegeneRx chairman and chief scientific advisor, and biochemistry and molecular biology professor at The George Washington University School of Medicine, said: "The significant reduction in the signs and symptoms of dry eye are consistent with the anti-inflammatory, anti-apoptotic and wound healing properties of thymosin beta 4, the active pharmaceutical ingredient in RGN-259."