iSTAR Medical has implanted the first patients in its international trial assessing the safety and efficacy of the company’s MINIject device when jointly used with cataract surgery for the treatment of primary open-angle glaucoma (POAG).
Tell me about the MINIject first.
The MINIject is a minimally-invasive glaucoma surgery (MIGS) device designed for use in patients with POAG; it is also currently the only commercially available supraciliary device in Europe (European Union, United Kingdom, and Switzerland).
It device enhances natural fluid flow from the anterior chamber (with a 0.5 nm implantation in the anterior chamber, away from the cornea) of the supraciliary space, leading to a significant reduction in intraocular pressure (IOP) and a limitation in inflammation, fibrosis, and other complications—all in a single-step procedure.
Any research on it?
Two-year follow-up data from a standalone trial on MINIject reported a meaningful reduction in IOP (< 15 mmHg) in most patients, with a mean IOP reduction of 35 to 40%. Almost 50% of patients were medication-free after 2 years, and overall medication use dropped 45% post-surgery within the same time period.
Further, a minor percentage of patients showed >30% endothelial cell density (ECD) loss at 2 years.
Now talk about the trial.
The STAR-VI trial is a prospective, interventional, multi-center, single-arm, international study with 30 participants across seven sites in Europe and Central America. All patients will undergo cataract surgery and concurrent MINIject implantation, and be followed for 2 years post-surgery.
The primary endpoint of the trial will include measuring the proportion of patients who achieve a ≥20% reduction in diurnal IOP from baseline to 6-month follow-up, regardless of the use of IOP lowering medication.
What are they evaluating?
The trial’s primary endpoints include safety and tolerability; secondary endpoints include objective identification, contrast assessment, navigational, functional, and other ophthalmic and quality-of-life assessments.
By concurrently targeting both glaucoma and cataract surgery, the MINIject has the potential to treat a wider patient base and minimize patient recovery time.
iSTAR Medical is aiming to seek market approval in the United States at an undisclosed date in the future.