Home / Drugs & Interventions / RGN-259 / History RGN-259 History and Updates 17 events · 2015 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026 .
RGN-259 — history and updates FDA approvals, label revisions, recalls, trials, and pivotal publications FDA approvals Label revisions Recalls + safety Trials Publications 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 Trial: 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-2 Results posted — 2023-08-14
Trial results posted: NCT02600429
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1 today (2026-05-08) FDA approval Label revision Recall or safety Trial activity Pivotal publication Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-08 Download 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 Apr 30, 2026 · 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 Aug 14, 2023 · ClinicalTrials.gov
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Trial started Apr 11, 2023 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
2022
Trial registered Sep 27, 2022 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2
Results posted Jan 5, 2022 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
2020
Primary completion Nov 8, 2020 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
2019
Primary completion Nov 20, 2019 · ClinicalTrials.gov
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Trial started May 24, 2019 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
Trial registered May 6, 2019 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3
2017
Primary completion Sep 30, 2017 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
2016
Trial started Nov 30, 2016 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Trial registered Nov 29, 2016 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Primary completion Jun 30, 2016 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
2015
Trial registered Nov 9, 2015 · ClinicalTrials.gov
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Trial registered Nov 5, 2015 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
Trial started Sep 30, 2015 · ClinicalTrials.gov
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1
Trial started Sep 17, 2015 · 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.