Ivantis Announces First Patient Enrolled in Pivotal Clinical Trial Evaluating the Hydrus Microstent in Standalone MIGS for Mild to Moderate Glaucoma

IRVINE, Calif., Dec. 15, 2021 /PRNewswire/ -- Ivantis Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device intended to lower eye pressure for open-angle glaucoma patients, today announced that the first patient has been enrolled in a pivotal clinical trial evaluating the Hydrus Microstent in patients with mild to moderate open-angle glaucoma, without concurrent cataract surgery. Up to 80% of glaucoma patients have mild to moderate disease severity, and a standalone Hydrus Microstent procedure could provide an important new treatment option in the U.S.

Currently in the U.S., MIGS implants are approved only in conjunction with cataract surgery, not as a standalone procedure. The FRONTIER trial will evaluate the effectiveness of the Hydrus Microstent in patients who have already had cataract surgery, making the study a vital addition to the growing body of evidence on the Hydrus Microstent.  

Outside the U.S., the Hydrus Microstent is routinely performed as a standalone MIGS procedure (in addition to concurrent with cataract surgery), and prior studies have shown a reduction in both intraocular pressure (IOP) and medication use.¹ The Hydrus Microstent has also been shown to reduce peaks and fluctuations in the diurnal IOP curve.²

The FRONTIER trial will build on long-term findings from the Hydrus HORIZON five-year pivotal trial, which showed a 47% reduction in visual field loss, sustained reduction in medication use, and over 60% reduction in subsequent, more invasive glaucoma surgery.^3,4 The Hydrus Microstent is the only MIGS device to complete a pivotal trial with five-year follow up data showing both durable safety and efficacy. It also stands alone in receiving the highest grade for quality body of evidence and a strong recommendation among MIGS rated in the 2020 American Academy of Ophthalmology Primary Open-Angle Glaucoma Preferred Practice Pattern (PPP). ⁵

"The Hydrus Microstent has already demonstrated significant clinical benefits in terms of glaucoma progression when used in combination with cataract surgery. FRONTIER will reveal important new findings on Hydrus as a standalone MIGS procedure. The trial's inclusion and exclusion criteria allow for a broad population to be treated," said Nathan Radcliffe, MD, medical monitor for the FRONTIER trial and associate clinical professor of ophthalmology at Mount Sinai School of Medicine.

The FRONTIER trial will include up to 32 study sites inside and outside the U.S., and will comprise:

• 234 eyes treated with the Hydrus Microstent (single-arm study) in patients with prior cataract surgery with no complications (pseudophakic), no prior MIGS, cilioablation or incisional glaucoma surgery
• Primary effectiveness endpoints evaluated at one year with follow-up through two years for safety
• Co-Primary effectiveness endpoints:
• Proportion of subjects with ≥ 20% unmedicated DIOP reduction at 12M vs baseline
• Mean change in unmedicated DIOP at 12M vs baseline

"We have followed thousands of eyes in trials and registries in both combination cataract and standalone surgeries, and our belief is that no other MIGS device provides the safety and efficacy of Hydrus as a durable, reconstructive, and permanent implantable solution — the data show sustained long-term benefit," said Dave Van Meter, president and CEO of Ivantis. "With the FRONTIER trial, we are embarking on an exciting opportunity to change the course of the disease in the U.S., offering hope for thousands of glaucoma patients and the practitioners who care for 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 dilates and scaffolds Schlemm's canal to augment outflow of aqueous humor from the anterior chamber.
2. It maintains an opening through the trabecular meshwork from the anterior chamber into Schlemm's canal.
3. Its length spans approximately 90 degrees of the canal to provide consistent access to multiple fluid collector channels in the eye.

Approved by the FDA in August 2018 for use in conjunction with cataract surgery, 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.

About Ivantis 
Ivantis Inc. is a privately held company established in 2007 to design, develop, and commercialize new technologies to treat eye disease. Investors include New Enterprise Associates, Delphi Ventures, Foresite Capital, RA Capital Management, Ascension Ventures, EDBI, GBS Ventures, MemorialCare Innovation Fund, Merieux Development, and Vertex Healthcare. The company is headquartered in Irvine, California.

Ivantis, Hydrus, and Tri-Modal are registered trademarks of Ivantis Inc. All rights reserved 2021.

References

1. Ahmed IIK, Fea A, Au L, Ang RE, Harasymowycz P, Jampel HD, Samuelson TW, Chang DF, Rhee DJ; COMPARE Investigators. A Prospective Randomized Trial Comparing Hydrus and iStent Microinvasive Glaucoma Surgery Implants for Standalone Treatment of Open-Angle Glaucoma: The COMPARE Study. Ophthalmology. 2020 Jan;127(1):52-61. doi: 10.1016/j.ophtha.2019.04.034. Epub 2019 Apr 26. PMID: 31034856.
2. Posarelli C, Ortenzio P, Ferreras A, Toro MD, Passani A, Loiudice P, Oddone F, Casini G, Figus M. Twenty-Four-Hour Contact Lens Sensor Monitoring of Aqueous Humor Dynamics in Surgically or Medically Treated Glaucoma Patients. J Ophthalmol. 2019 Jan 27;2019:9890831. doi: 10.1155/2019/9890831. PMID: 30809389; PMCID: PMC6369465.
3. Ahmed IIK, Rhee DJ, Jones J, Singh IP, Radcliffe N, Gazzard G, Samuelson TW, Ong J, Singh K; HORIZON Investigators. Three-Year Findings of the HORIZON Trial: A Schlemm Canal Microstent for Pressure Reduction in Primary Open-Angle Glaucoma and Cataract. Ophthalmology. 2021 Jun;128(6):857-865. doi: 10.1016/j.ophtha.2020.11.004. Epub 2020 Nov 6. PMID: 33166551.
4. Gazzard et al. AGS 2022 Abstract (in review)
5. Primary Open-Angle Glaucoma Preferred Practice Pattern^®. Gedde, Steven J. et al. Ophthalmology 2020;128(1): 71-150)

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%); worsening in visual field MD by > 2.5 dB compared with preoperative (4.3% vs. 5.3% for cataract surgery alone); device malposition (1.4%); and BCVA loss of ≥ 2 ETDRS lines ≥ three months (1.4% vs. 1.6% 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 conditions; please see the Instructions for Use and Patient Information Card for details.

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

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SOURCE Ivantis, Inc.