CyPass MIGS System Now Features Pre-Loading

■ Alcon has introduced the CyPass Ultra System, designed to streamline the process of loading the CyPass Micro-Stent, a MIGS device indicated for use in adult patients with mild to moderate primary open-angle glaucoma undergoing cataract surgery. The new system reduces the number of steps required to implant the CyPass.

“The introduction of the new CyPass Ultra System shows our commitment to partner with surgeons and continuously innovate in the surgical glaucoma space to ensure our technology delivers the best surgical experience possible,” said Sergio Duplan, region president for North American operations at Alcon, in a news release. “This new pre-loaded system makes it easier for surgeons to deliver optimal outcomes for their glaucoma patients undergoing cataract surgery.”

The CyPass Ultra System includes a pre-loaded CyPass Micro-Stent housed in a loader tip attached to a handheld surgical instrument called the CyPass applier.

Alcon assessed the use of CyPass Micro-Stent in conjunction with cataract surgery in a randomized, multi-center clinical trial, compared to cataract surgery alone in 100 subjects. Results demonstrated a long-term decrease in IOP and minimal effects on refractive outcomes, according to the company.

Glaukos iStent Inject Excels in Comparative Study

■ Glaukos Corporation said 2-year U.S. Investigational Device Exemption pivotal trial data showed that its iStent inject trabecular microbypass system achieved a statistically significant reduction in unmedicated diurnal intraocular pressure (IOP) in patients undergoing cataract surgery.

Results of the prospective, randomized, multicenter clinical trial were presented at the recent ASCRS annual meeting. In the study, 387 subjects were randomized to iStent inject in combination with cataract surgery, and 118 subjects were randomized to cataract surgery only. Subjects were followed through 24 months with annual medication washouts.

The iStent inject met the study’s primary and secondary effectiveness endpoints, including the following:

• At 24 months, 75.3% of the iStent inject cohort achieved a 20% or greater reduction in unmedicated IOP, compared to 61.9% for the cataract-only cohort.
• At 24 months, the mean unmedicated IOP reduction was 6.9 mmHg for the iStent inject cohort, compared to 5.4 mmHg for the cataract-only cohort.

The iStent inject is designed to improve aqueous humor outflow into Schlemm canal and reduce IOP in mild-to-moderate open-angle glaucoma patients undergoing cataract surgery. It includes 2 heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point. The iStent inject relies on the same fluidic method of action as the company’s first-generation iStent trabecular microbypass stent, which was approved by the FDA in 2012 and has been shown to lower IOP in adult cataract patients with mild to moderate open-angle glaucoma. Each iStent inject stent is approximately 0.23 mm x 0.36 mm, or about one-third the size of iStent, which the company believes is the smallest medical device ever approved by the FDA.

Glaukos submitted a premarket approval application for the iStent inject to the FDA in December 2017.

Hydrus Microstent Performs Well in United States Trial

■ Ivantis announced positive US clinical trial data for its Hydrus Microstent MIGS procedure at the recent ASCRS meeting in Washington, DC. The global HORIZON pivotal trial results were previously presented at the AAO meeting in November 2017. Ivantis has filed a premarket approval submission with the FDA for the Hydrus.

The HORIZON trial compared reductions in IOP and ocular hypotensive medication use in patients having cataract surgery, with and without the Hydrus Microstent. Patients in the study had mild to moderate primary open-angle glaucoma and were taking 1 to 4 eye drops. The 24-month US cohort data, analyzed with intention-to-treat methodology, showed the following:

• 79% of the Hydrus Microstent patients achieved a 20% or greater reduction in IOP, compared to 55% in the cataract only group for a difference of 24%.
• Hydrus Microstent reduced IOP 50% more than cataract surgery alone (7.9 mmHg vs 5.2 mmHg, a difference of 2.7 mmHg).
• Twice the number of Hydrus patients remained medication free compared to the control group (79% vs. 39%).
• Of patients on 1 eye drop at entry into the study, 87% were medication free compared to 38% in the control group. GP