iSTAR Medical’s MINIject Shows Consistent Results at 18-Month Follow-Up in First-in-Human Trial

iSTAR Medical SA, a private medical device company developing novel ophthalmic implants for the treatment of glaucoma, has 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.
 
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 one 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 of the University of Toronto (Ontario, Canada), who performed some of the first MINIject procedures in the STAR-I trial, commented: “The stable pressure between one 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).
 
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.

The STAR I trial is a prospective, open, international, multi-center study in which MINIject was implanted in 25 patients with mild to moderate, primary, open-angle glaucoma uncontrolled by topical hypotensive medication. The aim of the study is to assess the safety and performance of the MINIject device measured by IOP reduction under medication from baseline to six months, with follow-up to two years post-surgery.

iSTAR Medical SA, headquartered in Wavre, Belgium, is a private, clinical-stage medical technology company focused on the development of ophthalmic implants for glaucoma.

Glaucoma is the second leading cause of adult blindness globally, affecting more than 92 million people worldwide. Micro-invasive glaucoma surgery (MIGS) is the most promising and fastest-growing therapeutic option in the treatment of glaucoma. iSTAR has exclusive rights to the STAR biomaterial from the University of Washington (Seattle) for ophthalmic use. This provides the foundation for the development of MINIject, designed to be a best-in-class MIGS device. The fast-growing glaucoma drainage device market is expected to reach $1 billion worldwide by 2020.