RGN-259 History and Updates

17 events · 2015 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
17
Trial Milestones
0
Pivotal Publications
RGN-259 — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20162017201820192020202120222023202420252026Trial: NCT05555589 2023-04-11 → 2026-04-30 (primary completion)Trial: NCT03937882 2019-05-24 → 2020-11-08 (primary completion)Trial: NCT02974907 2016-11-30 → 2017-09-30 (primary completion)Trial: NCT02597803 2015-09-30 → 2016-06-30 (primary completion)Trial: NCT02600429 2015-09-17 → 2019-11-20 (primary completion)Results posted — 2022-01-05 Trial results posted: NCT02974907 Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2Results posted — 2023-08-14 Trial results posted: NCT02600429 Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1today (2026-05-08)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for RGN-259 since 2015, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

Past events

2026
Primary completion· ClinicalTrials.gov
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
2023
Results posted· ClinicalTrials.gov
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Trial started· ClinicalTrials.gov
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
2022
Results posted· ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
2020
2019
Primary completion· ClinicalTrials.gov
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Trial started· ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
2017
2016
Trial started· ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
2015
Trial started· ClinicalTrials.gov
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.