Ivantis FDA Clinical Trial of the Hydrus Microstent for Minimally Invasive Glaucoma Surgery (MIGS) Meets Endpoints, Exceeds Outcomes of Past MIGS Trials
Ivantis, developer of the Hydrus Microstent, announced that the HORIZON pivotal study has met both the 2-year primary and secondary pre-established endpoints. Outcomes exceed those of any MIGS pivotal trial to date, according to a company news release. Ivantis previously announced that it submitted the final module of the PMA containing the HORIZON trial results to the FDA for market approval.
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 nine countries on three continents and was designed to demonstrate the safety and efficacy of the Hydrus Microstent in lowering intraocular pressure (IOP) in glaucoma patients undergoing cataract surgery.
According to a presentation by Paul Harasymowycz, MD, given during the American Academy of Ophthalmology annual meeting in New Orleans, LA, the two-year follow-up data from the HORIZON trial showed that:
- 77.2 percent of Hydrus Microstent patients achieved a 20 percent or greater reduction in IOP, compared to 57.8 percent in the cataract-only group, the largest treatment effect reported in a MIGS pivotal trial at 24 months.
- Hydrus Microstent reduced IOP 43 percent more than cataract surgery alone (7.6 mmHg vs. 5.3 mmHg), the largest difference in IOP reduction reported in a MIGS pivotal trial at 24 months.
- 78 percent of Hydrus Microstent patients remained medication-free compared to 48 percent in the control group, again the highest margin of total medication elimination compared to control of any MIGS pivotal trial at 24 months.
- The treatment effect in the Hydrus Microstent group increased from year one to year two as compared to the control group, suggesting an increasing benefit over time.
"This was a very well-run trial, producing excellent, convincing, and compelling results," Thomas W. Samuelson, MD, Global Medical Advisor for Ivantis, and Vice President/President-elect of the American Society of Cataract and Refractive Surgeons, said in the news release. "Once again, as with the other MIGS trials previously published, the control group demonstrates that cataract surgery alone is an effective IOP lowering procedure, but that IOP lowering can be effectively enhanced in a safe, clinically meaningful, and enduring fashion with the Hydrus Microstent. Among the impressive results seen in HORIZON, what stands out to me is the increasing benefit over time with Hydrus Microstent versus cataract surgery alone. These results strengthen the case for the use of MIGS as the preferred approach for most patients with mild to moderate glaucoma undergoing cataract surgery."
"It's gratifying to see these results from the HORIZON Trial," said Jason Jones, MD, (Sioux City, IA) a principal investigator in the HORIZON trial and one of the highest volume cataract surgeons in the country. "I am a very busy anterior segment surgeon, and I require a MIGS solution that is efficient to implant, adds little risk, and offers glaucoma patients the best chance to be eyedrop-free when they leave our office. The Hydrus Microstent offers all of these and seems to do so with consistency. I am confident in the procedure and pleased to see that the broader HORIZON results mirror the experience in our clinic."
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:
- The Hydrus Microstent creates a bypass through the trabecular meshwork, allowing outflow of aqueous humor.
- It then dilates and scaffolds Schlemm's canal to augment outflow.
- 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 3,500 cases treated globally, in patients with a wide range of disease severities. Ivantis is preparing for the commercial release of the Hydrus Microstent, anticipating market approval in 2018.
"We are grateful to all of the HORIZON Study Investigators and research teams across the globe for their outstanding contributions in advancing not only the Hydrus Microstent clinical program but the MIGS category overall," Dave Van Meter, President and CEO of Ivantis, said in the news release. "With these results, we've been able to demonstrate best-in-class clinical evidence in another top-level randomized controlled trial utilizing the ANSI Standard for implantable glaucoma devices, the highest level of evidence defined by the Food and Drug Administration. These excellent results give us great confidence that the Hydrus Microstent can become the standard of care for both cataract and glaucoma surgeons for the majority of their glaucoma patients undergoing cataract surgery."
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