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: ocular discomfort changed +0.07 on RGN-259 versus −0.04 on placebo, and corneal fluorescein staining +0.07 versus −0.01 (lower is better on both scales). 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 without a peer-reviewed report; no measure of dispersion or p-values posted, though the direction of both estimates is unambiguous. 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.