www.fdanews.com/articles/176624-regenerxs-dry-eye-treatment-flops-in-phase-23
RegeneRx’s Dry Eye Treatment Flops in Phase 2/3
May 12, 2016
RegeneRx Biopharmaceuticals’ dry eye candidate RGN-259 missed its primary endpoints in a Phase 2/3 trial, failing to show statistically significant improvements in either total ocular discomfort or total corneal fluorescein staining.
Despite the failed results in the 317-patient trial to treat severe dry eye, the company said that the drug showed significant results in several endpoints, such as “fast-acting treatment effect” on dry eye symptoms when exposed to an adverse environment or natural environment after 28 days of dosing, the company says. No adverse events were observed.