■ MIGS technical pioneer iSTAR Medical announced positive results of the STAR-II European trial for its MIGS device, MINIject. The data, presented at the 125th American Academy of Ophthalmology meeting in New Orleans, show favorable performance and safety profiles in patients with primary open-angle glaucoma (POAG) after 2 years of follow-up. The MINIject device has been approved for use in Europe for patients with open-angle glaucoma.
The STAR-II European trial with 29 patients showed MINIject produces a mean IOP reduction of 36% at 2-year follow-up, with a 52% reduction in glaucoma medication use at trial completion. It was also found consistent with “good corneal health,” important to long-term safety, the maker noted.
“The remarkable outcomes observed throughout the European trial keep adding to a significant body of evidence showing how MINIject offers a powerful, bleb-free option for the treatment of patients with [POAG],” said trial results presenter I. Paul Singh, MD, in a news release. “This may enable more effective glaucoma management and better quality of life for patients [who] need lower IOP and who are uncontrolled or struggling to comply with multiple medications.”
In addition, interim data from the ongoing long-term STAR-GLOBAL trial of existing MINIject patients indicate that the implant’s efficacy and safety have been maintained for up to 3 years. The device is also being investigated in iSTAR Medical’s 350-patient STAR-V study, which will be instrumental in gaining FDA approval for the US market, according to the company.
MINIject is implanted into the supraciliary space, a natural fluid-drainage pathway for the reduction of eye pressure. Unlike earlier supraciliary MIGS devices, MINIject has not been associated with fibrosis or substantial damage to corneal cell health, the manufacturer said. GP