A Phase 3 trial investigating the ab externo approach for the Glaucoma Gel Stent (XEN45) in participants with Glaucoma reached primary completion on 2026-02-04, with 74 participants enrolled.
Background
Glaucoma is recognized as the second most common cause of blindness globally, following cataracts. The XEN45 Glaucoma Gel Stent is an approved device for treating glaucoma when implanted using an ab interno approach, meaning from inside the eye. This study specifically investigated the safety and effectiveness of implanting the XEN45 stent using an ab externo approach, from outside the eye, which represents a different surgical technique for delivering an established device.
Trial design
This completed Phase 3 study enrolled 74 participants aged 45 years or older with Open-Angle Glaucoma. The trial's objective was to assess the safety and effectiveness of the Glaucoma Gel Stent (XEN45) when implanted using an ab externo approach. The study planned to assess adverse events and intraocular pressure.
What this means
The primary completion of this Phase 3 trial indicates that data collection for the study has concluded. While specific results regarding the safety and effectiveness of the ab externo approach for XEN45 implantation are not yet available, the completion of this phase is a step towards understanding a potentially new surgical option for patients with open-angle glaucoma. The findings, once published, will inform clinicians and patients about the viability and outcomes of this alternative implantation technique for an already approved device.
Source
The information regarding this trial's primary completion was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT05411198, titled "Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma", was updated with primary completion on 2026-02-04 on clinicaltrials.gov.