ReGenTree reports Phase III data for RGN-259 in dry eye syndrome

In October, ReGenTree LLC reported data from the Phase III ARISE-2 trial in 601 patients with dry eye syndrome showing that RGN-259 (GBT-201) significantly reduced ocular discomfort from baseline to day 15 vs. placebo (p=0.0149). In a subgroup of patients with both compromised corneal fluorescein staining and Schirmer’s test at baseline, RGN-259 significantly reduced corneal fluorescein staining from baseline to days 15 and 29 vs. placebo (p=0.0207 and p=0.0254, respectively).

The double-blind, U.S. trial is evaluating changes in ocular discomfort and corneal fluorescein staining from baseline to day 29 as its primary endpoints. Secondary endpoints include differences in corneal fluorescein staining, unanesthetized Schirmer’s test, Ocular Surface Disease Index (OSDI) and tear film break-up time between RGN-259 and placebo. Patients received placebo or RGN-259 eye drops given four times daily for 28 days...