iSTAR Medical SA announced consistent 18-month results of the first-in-human, micro-invasive glaucoma surgery (MIGS) STAR-I trial for the MINIject device in a standalone setting. These results confirm the stability and sustained performance of MINIject beyond the first year, according to a company news release.
The STAR-I trial demonstrated that the implantation of MINIject resulted in a mean pressure of 15.0 mmHg at 18-months, consistent with results reported at 1 year, and at a level expected to reduce the progression of glaucoma. In addition, almost two-thirds of the patients were able to stop taking their eye drops. These results confirm that the safety and effectiveness of MINIject is sustained over time, with minimal patient-management required.
“The stable pressure between 1 year and 18 months is reassuring as to the sustained performance of MINIject over time,” Ike Ahmed, MD, University of Toronto, Ontario, Canada, who performed some of the first MINIject procedures in the STAR-I trial, said in a company news release. “MINIject’s STAR material and its use in the supraciliary space is a promising combination.”
Early 6-month results of MINIject in the STAR-I trial were published online in June in Ophthalmology-Glaucoma, the journal of the American Glaucoma Society (AGS). The 18-month results of MINIject will be presented in detail on Friday, September 13, 2019, during Glaucoma Day at the ESCRS congress in Paris, France.
“iSTAR Medical is setting new frontiers in MIGS treatment of glaucoma. We are thrilled to see MINIject’s powerful and reliable efficacy in a standalone procedure sustained over time, without a trade-off between safety and efficacy, and without requiring invasive follow-up procedures or surgeries,” Michel Vanbrabant, CEO of iSTAR Medical, said in the news release. “We look forward to bringing this therapeutic option in the supraciliary space to market for glaucoma patients.”
iSTAR Medical has also completed enrollment in STAR-II, a pivotal European trial. The results of STAR-II will support the company’s application for CE-Marking for MINIject, which is expected in 2020.