iSTAR Medical's MINIject shows consistent results at 18-month follow-up in first-in-human trial (STAR-I)

WAVRE,Belgium,July 10,2019 -- iSTAR Medical SA,a private medicaldevice company developing novel ophthalmic implants for the treatment of glaucoma,todayannounced 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.

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,whoperformed 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 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,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.

http://www.istarmed.com/wp-content/uploads/2019/07/iSTAR_MINIject-FIH-trial-18-month-results-EN.pdf