The MINIject glaucoma drainage device, composed of a biocompatible porous silicone material, is a novel MIGS implant developed to target the suprachoroidal space. Six-month data have been previously published; this study evaluated the efficacy and safety of the MINIject device over a 2-year follow-up period.
Study design
This was a prospective, multicenter, first-in-human, single-arm interventional study in Panama and India of 25 patients with primary open-angle glaucoma. All patients had IOP between 21 and 35 mm Hg and were taking 1 or more glaucoma medications, which were discontinued postoperatively and reintroduced if IOP decreased by <20% or as deemed necessary. The primary outcome measure was reduction of IOP 6 months postoperatively. Follow-up continued for 2 years in 21 of the 25 patients.
Outcomes
Mean IOP reduced from 23.3 ± 2.9 mm Hg at baseline to 13.8 ± 3.5 mm Hg at 24 months, a 41% reduction. The number of glaucoma medications needed also decreased at 24 months, from 2.0 ± 1.1 medications at baseline to 1.0 ± 1.3 medications. Forty-eight percent of patients were considered a complete success, defined as a diurnal IOP of ≤21 mm Hg and >5 mm Hg, as well an IOP reduction of 20% without needing glaucoma medication. Mean endothelial cell density (ECD) decreased by 5% over the course of the study.
Limitations
A potential comparable supraciliary stent, the Cypass, was voluntarily removed from the global market due to decreased ECD in patients who received the device. A trend toward decreased ECD was shown in this study of the MINIject, a potential cause for concern. This study also had a relatively small sample size.
Clinical significance
Currently, there are no approved supraciliary MIGS shunts; therefore, if the MINIject is found to be safe and FDA-approved, it would be an additional option for glaucoma surgeons and their patients who are poor candidates for or have failed trabecular bypass surgeries.