ClinicalTrials.gov posted results on 28 August 2026 for ARISE-3, a completed Phase 3 trial evaluating RGN-259 ophthalmic solution for dry eye. The study enrolled 700 participants and compared RGN-259 with placebo; reported mean changes were generally close between the two groups.

Background

RGN-259 ophthalmic solution was studied for the treatment of the signs and symptoms of dry eye syndrome. The registered conditions were Dry Eye Syndromes and Dry Eye. The study objective was to compare the safety and efficacy of RGN-259 with placebo. The supplied record does not provide a drug-class description, mechanism of action, prior approval information, or prevalence estimates.

Trial design

ARISE-3 was a Phase 3 study with an overall status of completed. It enrolled 700 participants with dry eye syndromes or dry eye and included RGN-259 and placebo intervention groups. The protocol assessed ocular signs and symptoms, including corneal staining and ocular discomfort.

The supplied data do not list a primary outcome entry, statistical analysis, confidence interval, p-value, or adverse-event summary. The reported measurements therefore describe the available group-level results without establishing statistical significance or a formal treatment advantage.

Key results

For change from baseline in inferior corneal staining from pre- to post-controlled adverse environment at Day 15, the RGN-259 group had a mean of -0.41 score with a standard deviation of 0.841, compared with -0.46 score and a standard deviation of 0.804 for placebo.

For change from baseline in ocular discomfort at Day 15 before controlled adverse environment exposure, both groups had a mean of -0.4 score. The standard deviation was 1.12 with RGN-259 and 1.14 with placebo.

Additional fluorescein-staining measurements reported means of 8.46 versus 8.36, 8.20 versus 8.06, and 10.11 versus 9.95 for RGN-259 and placebo, respectively. The corresponding standard deviations were 2.960 versus 2.885, 2.996 versus 2.909, and 3.052 versus 3.018. A further reported measurement was 1.91 for RGN-259 and 1.92 for placebo, with standard deviations of 2.319 and 2.262.

What this means

The posted results provide comparative mean and variability data for RGN-259 and placebo in a Phase 3 dry-eye study. Across the listed measures, the reported group means were close, including identical mean ocular-discomfort changes.

Because the supplied record contains no primary outcome listing, statistical analysis, p-values, confidence intervals, or adverse-event summary, these data do not establish whether RGN-259 met a prespecified efficacy endpoint, differed from placebo in safety, or led to a regulatory decision.

Source

Source: ClinicalTrials.gov, registry record for “Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3,” NCT03937882, with results posted on 28 August 2026. The record is available at clinicaltrials.gov/study/NCT03937882.