MINIject® shows lasting 5-year efficacy in glaucoma treatment, STAR-GLOBAL trial reports

iSTAR Medical, a company at the forefront of eye care innovation, has unveiled promising five-year results from the STAR-GLOBAL trial concerning its MINIject® device, a minimally invasive glaucoma surgery (MIGS) implant. This announcement underscores the potential of MINIject® as a revolutionary treatment for glaucoma.

At the heart of iSTAR's announcement is the sustained efficacy of MINIject® over five years, as demonstrated in the STAR-GLOBAL trial. This trial is an extension of earlier European Union clinical studies that were designed to evaluate the long-term effectiveness and safety of MINIject® for glaucoma patients. Patients who had previously participated in these trials and used the MINIject® device were invited to continue their monitoring for up to five years under STAR-GLOBAL, allowing for comprehensive data collection over an extended period.

The MINIject® device, which is distinct in its supraciliary approach, claims to be the only such commercially available implant. Since its introduction, more than 5,000 patients across various markets have received the implant, showing consistent clinical benefits, particularly in reducing intraocular pressure (IOP), a critical factor in glaucoma management, while maintaining a strong safety record.

The five-year data from the STAR-GLOBAL trial, involving 47 patients who completed the extended monitoring period, revealed a significant 38% reduction in IOP from baseline values. Impressively, 83% of the patients experienced a reduction in IOP of more than 20%, and 80% saw their IOP drop to 18 or below by the end of the five-year follow-up. Notably, 32% of these patients were able to remain off medication entirely. The study also confirmed the device's safety, with no major adverse events related to the implant or the procedure over the course of the trial.

The results were presented by Andrew Tatham, an eminent Consultant Ophthalmologist and President of the UK and Ireland Glaucoma Society. Tatham emphasized the five-year follow-up data as a testament to MINIject®’s capacity to effectively and sustainably reduce IOP in patients over the long term, aligning with previous findings from earlier STAR trials.

Adding to the discourse, Dr. Karsten Klabe, a Chief Surgeon and major contributor to the STAR trials, highlighted the five-year findings as further evidence of MINIject®'s potential as a safe, standalone procedure for long-term glaucoma management.

Michel Vanbrabant, CEO of iSTAR Medical, expressed confidence in MINIject®’s ability to become a preferred surgical option for glaucoma treatment. He pointed to the consistent results over five years as reinforcing the company’s belief in the device’s capabilities. Vanbrabant also mentioned the company’s commitment to further research to establish MINIject® as a leader in surgical glaucoma interventions. With its promising track record, MINIject® stands poised to address unmet needs in major markets worldwide.

The company also announced the conclusion of its partnership with AbbVie, originally formed in 2022. Moving forward, iSTAR Medical will independently continue the development and commercialization of MINIject®, particularly focusing on ongoing trials in the United States, with an FDA submission anticipated by 2028, alongside continued efforts to expand its market presence in Europe and other global regions.

Overall, the five-year results from the STAR-GLOBAL trial validate the long-term efficacy and safety of the MINIject® device, reinforcing its position as a potentially transformative option in treating patients with glaucoma.