WAVRE, Belgium, Nov. 16, 2020 /PRNewswire/ --: iSTAR Medical, a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma, today announced positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, MINIjectTM. The results have been presented at the virtual American Academy of Ophthalmology (AAO) annual meeting, held 13-15 November 2020.
- Positive one-year results from the STAR-II European trial sustain the remarkable six-month outcomes and are consistent with the STAR-I trial results at one year
- Promising MINIject data at two years from the STAR-I trial were recently published in the British Journal of Ophthalmology
- Pre-clinical studies of MINIject highlighting the anti-fibrotic properties of its STAR® material were recently published in BMC Biomedical Engineering
STAR-II results at one year
At one-year follow-up, mean intraocular pressure (IOP) was 15.1 mm Hg, corresponding to a 38 percent reduction from medicated baseline IOP. Moreover, 45 percent of patients did not require any IOP-lowering medication one year after intervention (from a mean of 2.9 medications at baseline). In a post-hoc analysis in medication-free patients, IOP was reduced further by 46 percent to 13.1 mm Hg at one year. There were no significant overall safety issues, nor concerns with corneal health.
"The STAR-II results at one year confirm MINIject is a remarkably effective treatment option for patients with glaucoma. It is encouraging to see that the positive six-month results have been sustained at one year," explained Professor Julián García-Feijoó from Hospital Clinico San Carlos, Complutense University, Madrid (Spain) and a STAR-II study investigator, who presented the data at AAO.
The STAR-II trial enrolled 29 patients with open-angle glaucoma in eight centres in France, Germany and Spain. Patients will be followed for two years post-intervention.
Promising longer-term data
The one-year STAR-II data are consistent with the one-year outcomes from the first MINIject trial, STAR-I. The final results from STAR-I, which enrolled 25 patients followed-up for two years, have just been published in the peer-reviewed British Journal of Ophthalmology (BJO).1 Two year results of the STAR-I trial show sustained IOP reduction and no issues with corneal health.
Bio-integration and anti-fibrotic properties
The sustained performance shown by MINIject in patients may be connected to the bio-integration and anti-fibrotic properties of its STAR® material, according to pre-clinical trial results just published in the peer-reviewed journal BMC Biomedical Engineering.2
Studies conducted in rabbits showed that MINIject bio-integrates with surrounding tissue. The STAR material's porous structure gets colonised by neighbouring "healthy" cells that do not block the flow of aqueous humor through the device. Following this colonisation, no fibrosis, nor implant encapsulation, nor dense connective tissue obstructing drainage channels were observed, even though this animal model is known for its aggressive inflammatory response. Therefore, MINIject's bio-integration and anti-fibrotic properties may help preserve its permeability and enhance long-term outflow, resulting in enduring IOP reduction.
"The consistently positive results from MINIject trials are gaining strong attention from the scientific and medical communities for its potential to improve outcomes for patients with glaucoma," explained iSTAR Medical CEO, Michel Vanbrabant. "Our technology enables a new, truly bio-compatible approach for powerful, safe and enduring treatment, which we are eager to offer to patients soon," he concluded.
About iSTAR Medical
iSTAR Medical SA is a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma. iSTAR Medical has exclusive rights for ophthalmic use of the STAR® material developed by the University of Washington, Seattle (USA). STAR has outstanding anti-fibrotic and anti-inflammatory properties and a unique porous structure that enhances natural fluid outflow. iSTAR Medical was founded in 2011 and is headquartered in Wavre, Belgium. For more information: www.istarmed.com
MINIject is iSTAR Medical's revolutionary MIGS device for patients with primary open-angle glaucoma. MINIject combines the unique porous structure of its proprietary STAR material with the power offered by the supraciliary space. As a result, it is designed to enhance natural fluid outflow, reducing IOP and the need for medication, while bio-integrating with surrounding tissue, limiting inflammation, fibrosis and subsequent complications.
Glaucoma is a progressive disease and the second leading cause of adult blindness,3 affecting over 100 million people globally.3 IOP reduction, through medication or surgery, helps delay disease progression.3 Medication is generally the first line treatment, but the progressive addition of multiple drops can burden patients with side effects, compliance challenges and costs.3,4 Invasive surgery can present risks and irreversible complications.3,4 MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile.4 MINIject is potentially best-in-class for its promising long-term efficacy and safety.
1 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. British Journal of Ophthalmology. Published Online First: 03 October 2020. https://doi.org/10.1136/bjophthalmol-2020-316888
SOURCE iSTAR Medical