Alcon Introduces Preloaded Delivery System for the CyPass Micro-Stent

Alcon has announced the launch of the CyPass Ultra System designed to streamline the process of loading the CyPass Micro-Stent, a microinvasive glaucoma surgery (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 Micro-Stent, to help deliver safe, consistent, long-term IOP control.

“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,” Sergio Duplan, Region President, North America, Alcon, said in a company news release. “This new preloaded system makes it easier for surgeons to deliver optimal outcomes for their glaucoma patients undergoing cataract surgery.”

The CyPass Ultra System includes a preloaded CyPass Micro-Stent, which is housed in a loader tip attached to a hand-held surgical instrument called the CyPass applier. The CyPass Ultra System, along with the following data that reinforces the clinical value of the CyPass Micro-Stent, will headline the company’s clinical program at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting this year.

• Retrospective Review of Phacoemulsification Combined with a Suprachoroidal Stent Versus Phacoemulsification Combined with a Trabecular Bypass Stent for the Treatment of POAG (Drs. Steven Vold and Mike McFarland)
  • Key Findings: In a retrospective review comparing 100 eyes undergoing cataract surgery combined with the CyPass Micro-Stent to 100 eyes undergoing cataract surgery with the Glaukos iStent, a greater percentage of eyes in the CyPass Micro-Stent arm achieved IOP≤18 mmHg at 12 months post-surgery (82% vs. 55%, P<0.001). In addition, the mean IOP at 12 months post-surgery was 2.11 mmHg lower in the CyPass Micro-Stent arm (P<0.001).
• Interim Report Outcomes of a Supracilliary Micro-Stent in Primary Open-Angle Glaucoma Patients (Drs. William Clifford and Jaime Dickerson)
  • Key Findings: Interim results from the COMPASS extension study showed similar safety outcomes for CyPass Micro-Stent with cataract surgery as compared to cataract surgery alone, as well as sustained IOP lowering efficacy through 48 months post-surgery.
• Effect of Supracilliary Micro-Stent Implantation Concurrent with Cataract Surgery on the Accuracy of IOL Calculations in Patients with Open-Angle Glaucoma (Dr. Brian Flowers)
  • Key Findings: The CyPass Micro-Stent had minimal effects on predicted refractive outcome, and no statistical differences were found in refractive outcomes of 43 eyes undergoing cataract surgery with the CyPass Micro-Stent and 43 eyes undergoing cataract surgery alone.
• Noninterventional Study of Data Extracted from an EHR-Based Registry to Assess Long-Term Outcomes of a Supraciliary Micro-Stent (Drs. Stephen Lane, Flora Lum and Alvin Relucio)
  • Key Takeaways: In collaboration with the American Academy of Ophthalmology, Alcon plans to enroll 4,000 patients implanted with the CyPass Micro-Stent from the IRIS database over a 5-year period to collect real-world data that will be relevant to clinical usage and practice.

“Traditional treatment options for glaucoma patients can prove challenging for a variety of reasons, many of which reduce adherence and can worsen outcomes,” Dr. William Clifford, Fry Eye Associates, Garden City, Kansas, said in the news release. “We are excited about the long-term data that show the CyPass Micro-Stent has real promise for safely filling an unmet need in this population and can help reduce the reliance on topical medications.”

The CyPass Micro-Stent received FDA approval in 2016. This new preloaded system is expected to be widely available to surgeons in May 2018.