IVANTIS, INC.: Announces Groundbreaking 3 Year Results from FDA Clinical Trial; First Device in Minimally Invasive Glaucoma Surgical (MIGS) Category to Demonstrate Significant Long Term Reduction of Severe Major Surgeries for Glaucoma Patients

Ivantis, Inc. issued the following announcement on May 2.

Ivantis, Inc., developer of the novel Hydrus® Microstent, a micro-invasive glaucoma surgical (MIGS) device designed to lower eye pressure for open-angle glaucoma patients, announced today that the 3 Year Results from the HORIZON pivotal study.  The 2 year results, which were the foundation of FDA approval, were presented in November 2017, and were recently published in the leading journal Ophthalmology.  The 2 year effectiveness outcomes exceeded those reported in any other MIGS pivotal trial to date.  The product was approved in the US in August 2018.

The HORIZON study is the largest prospective, randomized, controlled trial conducted to date for a MIGS device, and the first to have a global span. The study included 556 patients and was conducted at 38 centers in 9 countries in North America, Europe, and Asia, and was designed to demonstrate the safety and effectiveness of the Hydrus Microstent in lowering intraocular pressure (IOP) in glaucoma patients undergoing cataract surgery.  The study included patients with mild-to-moderate glaucoma undergoing cataract surgery, and had a 2:1 randomization either to Hydrus Microstent plus cataract surgery, or cataract surgery alone.

The HORIZON 3 Year results will be presented by Thomas Samuelson, MD, President of the American Society of Cataract and Refractive Surgeons (ASCRS), at 1:58 pm on Sunday, May 5th, 2019 at the ASCRS Annual Meeting in San Diego. 

Key findings at 3 years include:

• 73 percent of Hydrus Microstent patients remained medication-free compared to 48 percent in the cataract only arm, still the highest margin of total medication elimination compared to control of any MIGS pivotal trial.
• Among patients who entered the study on 1 medication, which represents approximately half of the glaucoma patients in the US, 81 percent remained medication-free compared to 48 percent in the cataract only arm.
• Only 0.6 percent of Hydrus Microstent patients went on to subsequent invasive surgery to control glaucoma, compared to 3.9 percent in the cataract only arm, an 85 percent reduction in favor of Hydrus, and the first time in any MIGS study where a statistically significant reduction of invasive high risk secondary surgery has been shown.
• Overall safety profile similar to cataract surgery alone, including endothelial cell density (ECD) stability from year 2 to year 3, with no significant change between the Hydrus Microstent group and cataract surgery group.

According MIGS pioneering surgeon Iqbal ("Ike") Ahmed, MD, assistant professor at the University of Toronto, and distinguished Binkhorst medal recipient and lecturer on the topic of MIGS, "With these HORIZON 3 year results, we have now confirmed for the first time what we have long suspected and hoped, which is that earlier intervention with a canal microscaffold can significantly and safely reduce the need to move on to much more severe surgeries.  Invasive procedures, such as trabeculectomy, are life changing events for our patients, and often have devastating complications and adverse quality of life ramifications.  The Hydrus has demonstrated that scaffolding and reconstructing an entire quadrant results in a unique benefit to our patients that is profound.  My hope and belief is that this data will take MIGS to the next level and usher in a new wave of interventional glaucoma."

According to Dr. Samuelson, "Until now, the data narrative in MIGS has been around medication reduction and IOP lowering – both of which are important surrogate endpoints – but to date, nothing has demonstrated the ultimate goal, which is reduction of subsequent invasive surgery.  Ultimately, among my goals as a glaucoma specialist is to keep patients from losing vision, either from the disease itself, or from higher risk surgical procedures such as trabeculectomy or drainage devices.  Time to trabeculectomy should be a new metric to add to our quality of life measures for glaucoma patients.  With this data, we now see what the cumulative clinical benefit for the patient can be when you have used a Hydrus to both lower IOP and eliminate medications – there is a significant and proven ability to substantially reduce the likelihood of higher risk glaucoma surgery."

"Our singular goal at Ivantis is to help surgeons, through technology and clinical science, optimize their treatment decisions for their patients," said Dave Van Meter, President and CEO of Ivantis.  "This 'Triple Play' in a single study is a first in our space:  efficacy that is best in class, safety demonstrated through stable ECD and low adverse event rates, and now unequivocal impact on clinical outcomes resulting in reduction of invasive high risk secondary surgeries. We are thrilled to again raise the bar for clinical evidence in the MIGS space, and we are gratified over what this means for glaucoma patients and our surgeon customers who treat them."

About the Hydrus Microstent

Roughly the size of an eyelash, the Hydrus Microstent is a next-generation MIGS device designed to reduce eye pressure by reestablishing flow through Schlemm's canal, the eye's natural outflow pathway. When placed in the canal during minimally invasive microsurgery, the device restores the flow of fluid in the eye, using a tri-modal mechanism of action: 

1. The Hydrus Microstent creates a bypass through the trabecular meshwork, allowing outflow of aqueous humor.
2. It then dilates and scaffolds Schlemm's canal to augment outflow.
3. Its length spans 90 degrees of the canal to provide consistent access to the fluid collector channels in the eye.

The Hydrus Microstent is one of the most rigorously researched and thoroughly studied MIGS devices, with more than 4,000 cases treated globally in controlled clinical studies and registries, in patients with a wide range of disease severities.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

INDICATIONS FOR USE:

The Hydrus Microstent is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).

CONTRAINDICATIONS:

The Hydrus Microstent is contraindicated under the following circumstances or conditions: (1) In eyes with angle closure glaucoma; and (2) In eyes with traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber (AC) angle.

WARNINGS

Clear media for adequate visualization is required. Conditions such as corneal haze, corneal opacity or other conditions may inhibit gonioscopic view of the intended implant location. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, peripheral anterior synechiae (PAS), angle closure, rubeosis and any other angle abnormalities that could lead to improper placement of the stent and pose a hazard.

PRECAUTIONS

The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the Hydrus Microstent has not been established as an alternative to the primary treatment of glaucoma with medications, in patients 21 years or younger, eyes with significant prior trauma, eyes with abnormal anterior segment, eyes with chronic inflammation, eyes with glaucoma associated with vascular disorders, eyes with preexisting pseudophakia, eyes with uveitic glaucoma, eyes with pseudoexfoliative or pigmentary glaucoma, eyes with other secondary open angle glaucomas, eyes that have undergone prior incisional glaucoma surgery or cilioablative procedures, eyes that have undergone argon laser trabeculoplasty (ALT), eyes with unmedicated IOP < 22 mmHg or > 34

mmHg, eyes with medicated IOP > 31 mmHg, eyes requiring > 4 ocular hypotensive medications prior to surgery, in the setting of complicated cataract surgery with iatrogenic injury to the anterior or posterior segment and when implantation is without concomitant cataract surgery with IOL implantation. The safety and effectiveness of the use of more than a single Hydrus Microstent has not been established.

ADVERSE EVENTS

Common postoperative adverse events reported in the randomized pivotal trial included partial or complete device obstruction (7.3 percent); worsening in visual field MD by > 2.5 dB compared with preoperative (4.3 percent vs. 5.3 percent for cataract surgery alone); device malposition (1.4 percent); and BCVA loss of ≥ 2 ETDRS lines ≥ three months (1.4 percent vs. 1.6 percent for cataract surgery alone). For additional adverse event information, please refer to the Instructions for Use.

MRI INFORMATION

The Hydrus Microstent is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified condition, please see the Instructions for Use and Patient Information Card for details.

Please refer to the Instructions for Use for complete product information.

Original source can be found here.