Eyelash-size device restores fluid flow
By Katie Pfaff
Ivantis Inc. reported primary and secondary endpoints have been met for a pivotal study of its Hydrus microstent micro-invasive glaucoma surgical (MIGS) device. Outcomes from the Horizon study have outstripped previous MIGS trials, according to the company, which anticipates FDA approval in 2018.
Ivantis, of Irvine, Calif., reported positive two-year follow-up results of its Horizon study at the American Academy of Ophthalmology meeting in New Orleans. According to the research, Hydrus microstent provides the "largest treatment effect reported in a MIGS pivotal trial at 24 months." Ivantis submitted the final module of the PMA with Horizon trial results in October, and is planning for commercialization after market approval is gained.
Data reported indicated 77.2 percent of Hydrus microstent patients saw a 20 percent or higher reduction in intraocular pressure (IOP) while those in the cataract only group saw a 57.8 percent reduction in IOP. The device reduced IOP 43 percent more than cataract surgery (7.6 mmHg vs. 5.3 mmHg), and 78 percent were medication-free at 24 months compared to 48 percent of the control. Each endpoint was superior to prior MIGS research outcomes, according to Ivantis.
Study results suggest the greatest improvement against a control in a MIGS trial, said Dave Van Meter, president and CEO, Ivantis Inc. to BioWorld MedTech. The effect of the Hydrus stent compared to the control improved over time and "was even better at two years, actually increasing effectiveness over time relative to the control group," he said. The study also was the largest of its kind and included patients from various countries, said Van Meter. The global study included 556 patients across nine countries and 38 centers with glaucoma and who were undergoing cataract surgery, and being evaluated for safety and efficacy of the device. The stent is intended to reduce IOP and resulting damage to the optic nerve from glaucoma, which results from increased pressure in the eye.
Long-term results positive
"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," said Thomas Samuelson, global medical advisor, Ivantis, and vice president and president-elect of the American Society of Cataract and Refractive Surgeons. "Among the impressive results seen in Horizon, what stands out to me is the increasing benefit over time with Hydrus microstent vs. 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."
Hydrus, which is about the size of an individual eyelash, is intended to lower eye pressure among patients with open-angle glaucoma by recreating fluid flow out of the Schlemm's canal, restoring the eye's normal area of fluid flow. The device is placed in a MIGS procedure and employs three mechanisms of action, beginning with the microstent creating a path for the eye's humor around the trabecular meshwork, dilating the stent and scaffold in Schlemm's canal to expand the outflow area, and extending the device to a 90 degrees in the canal to open fluid channels in the eye.
MIGS market and competition
Schlemm's canal is one method of alleviating eye pressure during a MIGS procedure, while suprachoroidal shunts, subconjunctival filtration, and additional methods also are used. According to WHO, glaucoma impacts more than 80 million people globally and is the second leading cause of blindness, with about 2.5 million currently blinded due to the disease.
The large reach of the market brings various competitors to the MIGS space, including Glaukos Corp., Allergan plc and Alcon (a unit of Novartis AG) among others. Glaukos, of San Clemente, Calif., is going after FDA approval for its Istent Inject device, which places two stents in different areas of the eye's trabecular meshwork. The company previously received an FDA nod for the first iteration of its Istent device in 2012. The firm also earned $108 million in 2015 with its initial IPO. (See BioWorld MedTech, Oct. 18, 2017). Novartis, of Basel, Switzerland, added Transcend Medical Inc. to its Alcon brand in early 2016 deal for which financing was not disclosed. (See BioWorld MedTech, Feb. 19, 2016.) Under Alcon, the Transcend Cypass stent received FDA approval last summer based on data from the COMPASS study. (See BioWorld MedTech, Oct. 18, 2017). Allergan plc, of Dublin, Ireland, acquired Aquesys Inc., maker of the Xen MIGS stent, in a cash sale of $300 million in 2015. (See BioWorld MedTech, Sept. 8, 2015.)
Financial analyst, Larry Biegelsen, medical supplies and devices, Equity Research, Wells Fargo Securities LLC, commented on the significance of the data after its release. "The Horizon efficacy data on the surface looks better than Glaukos Corp.'s Gen 1 Istent IDE trial, in our opinion, which is consistent with the anecdotal feedback from our physician checks though confounders (for example, patient washout) and varying study designs make it somewhat difficult to cross compare between studies," said Biegelsen, in a comment on the study report. "Based on our checks, we would expect GKOS's next-gen Istent Inject to help close the efficacy gap with Hydrus and be the easiest of any of the MIGS devices to implant. Ivantis submitted Hydrus for FDA approval on Oct. 31, which would peg approval around mid-2018, if not slightly earlier. Our assumption continues to be that Hydrus will be approved a few months ahead of Istent Inject. We currently model Hydrus capturing 5 percent of the U.S. MIGS market in 2018, which assumes the company will market the device on its own."
Head-to-head trial data comparing Istent, Inject and Hydrus is underway though has not been released, according to Biegelsen.
Published November 14, 2017