iSTAR Medical announced the completion of enrollment in their first-in-human microinvasive glaucoma surgery (MIGS) trial for the MINIject device.
The first-in-human trial is a prospective, open, international, multicenter study that has recruited 25 patients with mild-to-moderate, open angle glaucoma uncontrolled by topical hypotensive medications for implantation with a MINIject device. Patient enrolment occurred in centers between June and October 2017. The aim of this study is to assess the safety and performance of the MINIject device measured by IOP reduction under medication from baseline to 6 months. Subsequent safety and performance will be measured at 12 and 24 months after surgery.
iSTAR Medical's MINIject device takes a new approach to drainage which represents a paradigm shift. Unlike other technologies, MINIject uses STAR material, a soft and flexible, medical-grade silicone which conforms to the eye anatomy. The porous geometry of the STAR material promotes bio-integration of surrounding tissue into the material which preserves drainage efficacy over time. In addition, anti-fibrotic properties minimise scarring and increase implant durability. MINIject provides a safe, effective and sustainable solution to significantly reduce IOP by enhancing aqueous humour outflow from the anterior chamber to the suprachoroidal space. Implantation is swift and predictable using an injecting mechanism in a single-step procedure.
"I am excited to be investigating this novel, next-generation, intuitive MIGS device with the iSTAR Medical team. MINIject offers the potential of an efficacious treatment which may be less fibrotic and thus more sustainable in the long-term," Ike Ahmed, MD, University of Toronto, Ontario, Canada, who performed some of the first MINIject procedures, said in a company news release.
"iSTAR Medical is proud to bring this innovative solution to patients suffering with glaucoma, a major cause of blindness globally," Michel Vanbrabrant, CEO of iSTAR Medical, said in the news release. "With our proprietary STAR material, and international support from leading experts, MINIject has the potential to become a best-in-class treatment for Glaucoma. Initial feedback from investigators is encouraging and we look forward to seeing the primary endpoint results next year."