Results from the multicenter, randomized Gold-standard Pathway Study investigating the Xen 45 gel stent (Allergan/AbbVie) vs trabeculectomy found the gel stent was statistically noninferior to trabeculectomy in eyes with open-angle glaucoma. This finding was based on the proportion of patients at month 12 achieving ≥20% IOP reduction from baseline without increase in topical IOP-lowering medications, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention, and a noninferiority test with 24% margins. Both treatments produced statistically significant reductions in IOP and medications from baseline over time. At month 12, mean IOP was 14.4 mmHg on 0.6 medications in the gel stent arm, and 11.8 mmHg on 0.3 medications in the trabeculectomy arm. The change in mean IOP from baseline was statistically greater after trabeculectomy, while the change in mean IOP-lowering medications was only numerically lower. The failure rate was also numerically lower post-trabeculectomy.

“The gel stent resulted in fewer postoperative interventions, faster visual recovery with better visual function at 6 months, and fewer AEs, and should thus be considered as a surgical option in eyes requiring IOP in the mid to low teens. Considering recently published studies reporting efficacy of the gel stent implanted ab interno at 3 and 4 years, prospective follow-up over a longer period should be performed,” the study authors wrote.