The Phase 3 SEER-2 clinical trial (NCT05555589) for RGN-259 ophthalmic solution, investigating its use for Neurotrophic Keratopathy (NK), reached primary completion on 2026-04-30. This milestone indicates that the final participant has been examined or received an intervention for the purposes of the primary outcome data collection.
Background
Neurotrophic Keratopathy is a rare degenerative corneal disease characterized by impaired corneal sensation, leading to persistent epithelial defects, ulcers, and potentially corneal perforation. Effective treatments are crucial for preventing vision loss and maintaining ocular surface integrity. The SEER-2 study aims to evaluate the safety and efficacy of RGN-259 in addressing this challenging condition.
Trial design
The SEER-2 study (NCT05555589) is a Phase 3 clinical trial designed to assess the safety and efficacy of 0.1% RGN-259 Ophthalmic Solution. The trial enrolled 70 participants with Neurotrophic Keratopathy. It is a comparative study, with interventions including RGN-259 and placebo, with the objective to compare these for the treatment of NK.
What this means
The primary completion of the SEER-2 trial signifies that data collection for the study's primary objectives is now complete. The next steps involve data analysis to determine the safety and efficacy profile of RGN-259 compared to placebo in treating Neurotrophic Keratopathy. The results from this Phase 3 trial will be critical in evaluating the potential of RGN-259 as a new therapeutic option for patients with NK.
Source
Information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT05555589, titled "Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2," was posted on 2026-04-30 on clinicaltrials.gov.