October 2015

 

GLAUCOMA

 

Glaucoma editors corner of the world

CyPass clinical study results and next steps


by Ellen Stodola EyeWorld Staff Writer

 
 

Reay H. Brown, MD

There has been a lot of talk about MIGS devices, which makes it seem like we have many to choose from. But in fact we only have onethe iStent. The iStent was the first MIGS device to be approved, and it is still the only MIGS device that is available in the U.S. That may be about to change. In this months Glaucoma editors corner of the world, Sean Ianchulev, MD, tells us about the CyPassa suprachoroidal MIGS devicethat if approved by the FDA would be the second available MIGS device.

The CyPass is a tubular implant that is placed into the suprachoroidal space. The implantation is done just above the iris insertion and just below the scleral spur and trabecular meshwork. The CyPass creates an intentional and controlled cyclodialysis. In the study, CyPass implantation was done in conjunction with cataract surgery, so approval will be specifically for implantation in patients undergoing cataract surgery. Although the results have not yet been published, Dr. Ianchulev tells us that the study achieved its major goalsa 20% reduction of IOP that lasted for 2 years. Like the iStent, the CyPass is a breakthrough technology. It opens up a new area for surgical glaucoma treatment. The iStent seeks to improve conventional outflow by achieving trabecular bypass and enhancing outflow into the collector channels and the distal outflow plexus. The CyPass targets a different pathway and seeks to improve nonconventional outflow through the suprachoroidal space. Since there have been no head-to-head studies of the iStent versus the CyPass, it is not possible to say whether one approach is better than the other. One intriguing question is whether the two technologies may be synergistic. In eyes with more advanced glaucoma, would implanting both an iStent and a CyPass lower IOP more than either device alone? As the first MIGS device, the iStent has blazed the trail for a new way of thinking about glaucoma surgery. MIGS devices are for the 9095% of glaucoma patients who have mild to moderate disease. As Dr. Ianchulev says, the CyPass is aimed at this same group. This is an exciting time for glaucoma surgery. We will be very fortunate to have a second MIGS device, and the competition between devices will be good for glaucoma patients.

Reay H. Brown, MD, glaucoma editor

 
CyPass Micro-Stent

Visualization of an implanted CyPass Micro-Stent Source: Transcend Medical

The micro-stent has completed a phase 3 clinical study and now has 2 years of safety and efficacy data

The CyPass Micro-Stent (Transcend Medical, Menlo Park, Calif.) is only the second MIGS device, behind the iStent (Glaukos, Laguna Hills, Calif.), that is entering into the approval process with the FDA in the U.S. Its recently completed and evaluated clinical trial results indicate positive 2-year data. Sean Ianchulev, MD, San Francisco, discussed the goal of the study and the next steps in the approval process before the CyPass makes it to market. Dr. Ianchulev is chief medical officer and vice president of medical affairs and business development, Transcend Medical, and clinical associate professor, University of California, San Francisco.

Goals of the study

The device falls into the innovative MIGS category and is unique as the first micro-stent for IOP lowering through stented suprachoroidal outflow enhancement. There has been tremendous innovation not only in bioengineering and clinical science, but in regulatory science as well. We have worked closely with the FDA through the years to develop a robust clinical validation strategy with strong, 2-year endpoints, which is becoming an industry standard, Dr. Ianchulev said.

The study was a full Premarket Approval (PMA) and not a 510K, he said, and it was rare in the field of glaucoma devices in ophthalmology. Unlike prior approvals, this is the first FDA study with long-term efficacy endpoints at 2 years. Now, it is the first PMA submission with statistically positive efficacy outcomes through 2 years of follow-up. The COMPASS study is also one of the largest in surgical glaucoma with 505 randomized patients. With so many patients, the trial took awhile to recruit because patients had to meet strict inclusion criteria for both cataract and glaucoma.

Dr. Ianchulev said Transcend Medical has not yet announced the results of its study because the process of filing with the FDA is still ongoing; however, the company has said that the primary and secondary endpoints were met at both 1 and 2 years. The primary efficacy endpoint is more than 20% washout IOP reduction from unmedicated baseline to 2 years, and the secondary endpoint is a mean IOP reduction from baseline to 2 years.

Next steps

Dr. Ianchulev said that patients in the study have completed follow-up and the data is available internally. The company is currently preparing the PMA submission to the FDA, which will take a couple of months. The FDA already has guidance that it has issued on MIGS, and this is the first study to fall completely in line with this guidance, Dr. Ianchulev said. This trial was designed to control bias and ensure that patients get a device that really workswith superior long-term efficacy over the IOP-lowering effect of cataract surgery. Since its a permanent implant, we want to make sure the risk/benefit equation is squarely in the patients interest. Dr. Ianchulev said that according to the timelines, Transcend Medical is well positioned to introduce the next MIGS device 23 years ahead of any other companies with MIGS technologies. The approval depends on the FDA review process. Although he didnt want to speculate on when the device would be approved, he believes the study has been done in such a way that the data is well monitored and follows FDA design and guidance.

How does this fit into the glaucoma treatment paradigm?

The CyPass study was done in the U.S. in combination with cataract surgery. Our patients are those with mild to moderate glaucoma, so about 90% of the glaucoma patients, Dr. Ianchulev said. Some of these patients were treated with drops and some were not. We think that this would be a compelling treatment option in mild-moderate glaucoma with cataract surgery in the U.S., he said. Outside the U.S., physicians are using the micro-stent as a standalone treatment. In fact, 50% of EU registry patients receive standalone treatment. It has been an exciting development program. We are creating a whole new category, not just a new product, Dr. Ianchulev said. He hopes the micro-stent approach will hold out and provide a real option for patients needing IOP control.

Editors note: Dr. Ianchulev has financial interests with Transcend Medical.

Contact information

Ianchulev
: sianchulev@transcendmedical.com

CyPass clinical study results CyPass clinical study results
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