Ivantis has revealed new data from its five-year HORIZON pivotal trial showing its Hydrus Microstent device lowers the rate of visual field loss by 47% versus cataract surgery alone.
In what the company has labelled a breakthrough finding, the minimally invasive glaucoma surgery (MIGS) system is now reportedly the first glaucoma procedure to reduce vision loss compared to standard medical treatment in a large randomized clinical trial since trabeculectomy – the gold standard surgical intervention – first did so in the Collaborative Initial Glaucoma Treatment Study more than 20 years ago.
The preliminary findings were presented on 13 November during the Original Paper session at the 2021 American Academy of Ophthalmology (AAO) meeting by Dr Iqbal “Ike” Ahmed, research director at the Kensington Eye Institute and director of the Glaucoma and Advanced Anterior Segment Surgery (GAASS) Fellowship Program at the University of Toronto.
The visual field findings are from work done by Dr Gus Gazzard, Professor of Ophthalmology at Moorfields Eye Hospital.
“This is a game-changer. Since the inception of MIGS, the impact narrative has been largely restricted to surrogate endpoints – IOP lowering and medication reduction,” Ahmed said.
“At three years, we saw that Hydrus was impacting the rate of invasive secondary surgery, which was exciting. Now at five years, we have data indicating the Hydrus is affecting the underlying disease itself, which alters forever how we think of MIGS.
“I applaud Dr Gazzard and commend Ivantis for its tireless commitment and investment in furthering the science of MIGS, without which we would not have these significant outcomes.”
Visual field loss
According to Ivantis, it’s well documented that each decibel reduction in visual field loss from glaucoma has a dramatic impact on patient quality of life and healthcare costs1. Even a slight loss of vision can create a cascade of medical costs, from added glaucoma medications, surgeries, and doctor visits to additional hospitalizations from fractures and falls, to lost productivity at work.
The new five-year data derive from a review of all visual field follow-ups from baseline through five years for patients in the HORIZON study.
Ivantis reported that the study itself is the largest prospective, randomized, controlled trial conducted for a MIGS device and the first with continuous five-year follow-up. It included 556 patients with mild to moderate glaucoma treated in 38 centres in nine countries in North America, Europe, and Asia. Patients were treated with cataract surgery plus the Hydrus Microstent or cataract surgery alone, respectively.
“The public health implications of these findings are enormous as a reduction in the rate of visual field progression has the potential to delay or prevent vision loss and blindness in millions of individuals afflicted with glaucoma worldwide,” said Dr Douglas Rhee, Professor and Chair of Ophthalmology at Case Western Reserve University and University Hospitals and president-elect of the American Society of Cataract and Refractive Surgeons (ASCRS).
“Several studies have shown that even small amounts of visual field loss can lead to limitations in common activities such as driving, reading, and a patient’s ability to exercise or go outside the house. Combining Hydrus with cataract surgery is an opportunity to treat patients early in their disease state. With a safe glaucoma surgery like Hydrus, the procedure can be performed in mild or early onset disease before significant visual loss has occurred.”
Mr Dave Van Meter, Ivantis president and CEO, said in 1925 Dr J. Stefansson of Winnipeg, Canada, published results of his pioneering bypass glaucoma drainage procedure using a T-shaped tube device in the American Journal of Ophthalmology3.
“Nearly 100 years later, his vision has come full circle with the pivotal findings that the Hydrus technology, and its revolutionary, flow enhancing design, reduces vision loss,” he said.
“Overnight, this finding makes MIGS one of the most essential solutions for the globally escalating glaucoma burden and further demonstrates the clinical benefit being provided to patients by Hydrus. It is tremendously gratifying to see the singularly significant impact of Hydrus on glaucoma patients and their quality of life.”
Other HORIZON findings
According to Ivantis, earlier results showed significant reductions in IOP, medication use, and secondary glaucoma surgeries:
- 73% of “mild” Hydrus Microstent patients (those on one glaucoma medication at baseline) remained medication-free at five years, compared with 48% in the cataract surgery-alone arm.
- There was a 20% to 30% improvement in the medication-free rate in the Hydrus group versus control at all time points. This represents the highest margin total of medication eliminations compared to a control group reported for any MIGS pivotal trial.
- With Hydrus, patients had a more than 60% (2.8x) reduction in the likelihood for requiring subsequent invasive glaucoma surgery — a clinically meaningful and statistically significant difference. Hydrus had a 2.5% rate of subsequent invasive glaucoma surgery, compared with 6.4% for cataract surgery alone.
- Confirmed safety at five years, including continued stability of endothelial cell loss compared to control.
More information on the Hydrus Microstent can be found here.
- Wang, Yue MD; Alnwisi, Sameh MD; Ke, Min PhD* The impact of mild, moderate, and severe visual field loss in glaucoma on patients’ quality of life measured via the Glaucoma Quality of Life-15 Questionnaire, Medicine: December 2017 – Volume 96 – Issue 48 – p e8019
- Gazzard et al. AGS 2022 Abstract (in review)
- Stefansson J. An operation for glaucoma. Am J Ophthalmol 1925;8:681-693.