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news.RegeneRx Biopharmaceuticals' RGN-259(Tß4 preservative-free eye drops) significantly improved signs and symptoms of severe dry eye in physician-sponsored Phase 2 trial.
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The double-masked study treated nine patients with severe dry eye with RGN-259 or vehicle control six times daily over a period of 28 days.
RGN-259 met key efficacy objectives with statistically significant sign, symptom improvements and was found to be safe and well-tolerated, compared to vehicle control, at various time intervals, including 28 days post-treatment.
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 vs. host disease, giving us some confidence that we may see a positive effect in various types of dry eye patients," Sosne added.
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.
The other improvements reported in the RGN-259-treated patients were tear film breakup time and increased tear volume production.