Eyeworld

I MIGS UPDATE N FOCUS 36 | EYEWORLD | JULY 2019 Contact information Herndon: leon.herndon@duke.edu Holland: eholland@holprovision.com Rhee: dougrhee@aol.com by Liz Hillman EyeWorld Senior Staff Writer "Frankly, I miss it," Dr. Rhee said. "I under- stand the safety concerns, but with everything in medicine, you're balancing. You're balancing the risk of going permanently blind from glaucoma versus a certain percentage of patients who could have corneal endothelial cell changes. … Maybe years later some of them may need an endothelial cell transplant. In that sense, I cer- tainly don't advocate being cavalier or disregard- ing potential complications, but we already have procedures and devices that can change the corneal endothelium, particularly tube shunts. Is CyPass the best procedure for extremely early glaucoma? Maybe not from what we've learned about the endothelial cell loss, but it's some- thing that I miss from our armamentarium, and I hope that the other manufacturers exploring this space will be successful." Since its withdrawal, Dr. Rhee said he has been using the Hydrus (Ivantis) more, but he pointed out that it's a trabecular meshwork bypass procedure—a different space. Dr. Hern- don said he had decreased his use of the CyPass prior to the recall because he had experienced unpredictable myopic shifts with some patients. When it comes to trimming the CyPass device, should it be sticking out more than intended in the anterior chamber, Dr. Rhee said revision needs to be carefully weighed against the status of the corneal endothelium. "A good discussion needs to be had with the patient about the risks with revision against the risk of potential endothelial cell transplant," Dr. Rhee said. Such revision, he continued, is presumed to stop endothelial cell decline, but at this point, we don't know. "We don't know what causes the cell loss, but we think it's mechanical. The presumption is if you trim it, the decline will stop," Dr. Rhee said. Dr. Herndon said he and his colleagues sent letters to patients who had received the CyPass, explaining in simple terms the potential for cor- neal damage and offering to see them in clinic. Dr. Herndon said he revised two CyPass devic- es that were too long but there was no evidence of corneal damage; in both cases he was going in to do another glaucoma procedure. I n August 2018 Alcon voluntarily withdrew CyPass Micro-Stent, a MIGS device placed in the supraciliary space to drain aqueous from the anterior chamber into the supra- ciliary and suprachoroidal space via the uveoscleral pathway, from the market due to the potential for endothelial cell loss. Nearly a year later, ophthalmologists share how they've communicated with patients, how they're monitoring patients and have managed cases with endothelial cell loss, and the void created by this device's withdrawal from the market. CyPass took advantage of the untapped suprachoroidal space, while other MIGS devices facilitate drainage into the trabecular meshwork or subconjunctivally. Leon Herndon, MD, said most trabecular meshwork options did not get pressures as low as he wanted and traditional subconjunctival surgeries—trabeculectomy and tube shunts—carry a higher risk profile. "I was excited about the suprachoroidal space because there was the potential for the very low pressures that I wanted," Dr. Herndon said. "I don't know that I've found anything yet in the angle to replace the pressure lowering that we often saw with CyPass." Alcon voluntarily withdrew CyPass from the market when 5-year follow-up from its COMPASS-XT study showed more than 30% endothelial cell loss in 27.2% (44/162) of patients who had received the device. 1 Accord- ing to a Safety Communication issued by the FDA after Alcon's voluntary recall, the endo- thelial cell loss rate appeared to be related to the number of visible retention rings extending to the anterior chamber. 2 An ASCRS CyPass Withdrawal Task Force was formed and issued a preliminary statement about the study findings, withdrawal, and diagnostic monitoring. 3 Dr. Herndon noted that of the patients in the COMPASS trial who had significant endo- thelial cell loss, very few had clinical findings. He also said that none of the patients in this trial required corneal surgery at the time of the 5-year data. Douglas Rhee, MD, said he finds the with- drawal from the market a "definite loss." CyPass: One year after its voluntary withdrawal At a glance • Glaucoma specialists describe the void that the CyPass with- drawal left in the MIGS space. • Five-year data showed endo- thelial cell loss in a clinically significant number of patients, prompting Alcon to voluntarily withdraw CyPass—the only FDA-approved MIGS device that facilitated aqueous outflow into the suprachoroidal space—from the market. • Glaucoma specialists would like to see CyPass or a similar device return to the market and describe how they would fit it in their armamentarium of MIGS options. • Some monitor CyPass patients with gonioscopy and pachym- etry, while others advocate for regular endothelial cell counts. Financial interests Herndon: Alcon, Glaukos, Sight Sciences, New World Medical Holland: None Rhee: None

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