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.
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.
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.