WAVRE, Belgium — 10 July 2019: iSTAR Medical SA, a private medical device company developing novel ophthalmic implants for the treatment of glaucoma, today announced consistent 18-month results of the first-in-human, micro-invasive glaucoma surgery (MIGS) STAR-I trial for the MINIjectTM device in a standalone setting. These results confirm the stability and sustained performance of MINIject beyond the first year.
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.
Dr Ike Ahmed, University of Toronto, Ontario, Canada, who performed some of the first MINIject procedures in the STAR-I trial, commented: “The stable pressure between 1 year and 18 months is reassuring as to the sustained performance of MINIject over time. MINIject’s STAR material and its use in the supraciliary space is a promising combination.”
Early six-month results of MINIject 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, 13 September 2019, during Glaucoma Day at the ESCRS congress in Paris, France.
Michel Vanbrabant, CEO of iSTAR Medical, added: “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. We look forward to bringing this therapeutic option in the supraciliary space to market for glaucoma patients.”
iSTAR Medical has also completed enrolment 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.