Clinical program

A comprehensive clinical trial program supports the development of MINIject^®, with positive combined results at two years from the STAR-I and STAR-II clinical trials shown below. ¹

Positive results for MINIject^®

Intraocular Pressure (IOP)

Meaningful IOP reduction to <15mmHg in most patients
~40% mean IOP reduction after two years
Trials designed with stand-alone procedure

Medication

Nearly half of patients medication-free after two years
Medication use reduced by 45% two years post-procedure
Significant reduction or elimination of medication side-effects such as eye irritation/burning, eye pain, and skin sensitivity/irritation around the eye ²

Reduced complications

Low re-intervention rate up to two years
Bleb-free and conjunctiva sparing procedure - no needling, no MMC required
Very low number of patients with >30% central endothelial cell density (ECD) loss at two years

Evidence-based data on safety and efficacy

More than 150 patients in clinical trials
11 trial centers throughout Europe, India and Latin America
MINIject assessed as stand-alone procedure – no enhancement of outcomes from joint cataract surgery
Published results after two-years of follow-up

¹ Data on file and presented by CEO Michel Vanbrabant at Ophthalmology Innovation Summits (OIS) in 2021.

² Denis P, Hirneiß C, Durr GM, et al. “Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial”. Br J Ophthalmol 2020;0:1–6

³ García Feijoó J, Denis P, Hirneiß C et al. “A European Study of the Performance and Safety of MINIjectTM in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)”. J Glaucoma. 2020 Oct;29(10):864-871

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MINIject Publications

Positive results for MINIject®

Evidence-based data on safety and efficacy

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Positive results for MINIject^®