Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-2

ReGenTree, LLC · ClinicalTrials.gov registration with posted results

Both co-primary endpoints at day 29 favoured placebo numerically, on scales where lower is better: ocular discomfort changed +0.07 (95% CI -0.05 to 0.19) on RGN-259 against -0.04 (-0.15 to 0.08) on placebo, and corneal fluorescein staining +0.07 (-0.06 to 0.20) against -0.01 (-0.13 to 0.12). Every interval spans zero and each pair overlaps. Serious adverse events were reported in 3 of 299 on drug and 2 of 302 on placebo, other adverse events in 19 and 21, and there were no deaths. The largest completed Tβ4 efficacy trial found no benefit.

Population

Adults with dry eye syndrome, multicentre US

Intervention

RGN-259 (0.1% thymosin β4) ophthalmic solution, 299 participants

Comparator

Placebo, 302 participants

Limitations

Registry-posted results with no peer-reviewed report and no p-values, though 95% confidence intervals are posted for both co-primary endpoints. The discomfort measure covers all 299 and 302 participants; the corneal-staining measure is posted for 111 and 107. No secondary outcome has any data posted. Sister trials ARISE-1 (NCT02597803, n=317) and ARISE-3 (NCT03937882, n=700) completed with no results posted and no journal report indexed as of August 2026.