Eyeworld

EW GLAUCOMA 74 July 2017 not be instilling the eye drops as directed, for reasons outside of their control," he said. "I don't think that patients are comfortable knowing that the major way to control their disease is in their hands." For physicians, there are ques- tions that still need to be answered. It may be necessary, for example, for glaucoma patients to come in more frequently than they normally would. "Physicians are going to have to figure out from an operational perspective how to logistically solve that issue," Dr. Aref said, adding that the other main factor is how payment for these devices is going to work. "Is it going to be treated like a procedure where physicians get paid for implanting the device? If so, what is going to be the uptake from insurance carriers? Is this going to be something that they're going to cover?" It remains to be seen whether they will want patients to try conventional eye drop therapy first, Dr. Aref said. Dr. Budenz concurred that the insurance piece of the issue needs to be sorted out. But in his view there is room in the market for all of these sustained-release mechanisms. "I think that the intraocular injections are working better, but doctors ar- en't going to want to stick needles in patients' eyes every 4 to 6 months," Dr. Budenz said. Likewise, with the pellets, it's unknown whether they are completely biodegradable or build up over time, he continued. So for early glaucoma, he expects that the ring or plugs will be used. Overall, Dr. Budenz thinks there is likely to be widespread accep- tance of the approach for doctors and patients. "The question is: Are payers going to pay for it? I hope they do because we've had a hard time getting drugs approved on the compliance argument alone, even though there is a lot of data saying that two-thirds of our patients don't take their drops as prescribed," he said. EW Editors' note: Dr. Aref has financial interests with Novartis (Basel, Switzer- land) and New World Medical (Rancho Cucamonga, California). Dr. Budenz has financial interests with Allergan, Envisia, Alcon, Inotek Pharmaceuticals (Lexington, Massachusetts), and Ivantis (Irvine, California). Contact information Aref: aaref@uic.edu Budenz: www.med.unc.edu/ophth it falling out," Dr. Budenz said. "It's safe because you're not injecting it inside the eye." It also wouldn't have local skin-changing effects. Still, it is very early, with a lot of uncertainties. "The question is if the drug is going to get into the eye and how does it get in," Dr. Budenz said. "Does it get in through the eye wall, or does it slowly elute through the hole that you made and get into the eye through the cornea? That wouldn't be good because that hole is going to close up." Internal approaches There are also intraocular drug de- livery systems. Dr. Aref said that the one furthest along is a bimatoprost sustained-release (SR) implant (Al- lergan) that is now in Phase 3 trials. The other is the travoprost implant (Envisia Therapeutics, Morrisville, North Carolina). "They come on the tip of an injector, and the physician penetrates the anterior chamber of the eye and injects the implant into the front of the eye," Dr. Aref said. "Once it's inside the eye, it lowers the eye pressure the same way that an eye drop would." The advantage of these over the punctal plug or ring is that the du- ration of effect is much longer. "The studies are suggesting that we're getting 6 months of good efficacy, and perhaps with better iterations and improvements, we can get up to 9 months or even longer," Dr. Aref said. Dr. Budenz reported that in Phase 2 studies the bimatoprost SR had as much as 8 to 10 mm Hg pressure lowering at week 2. Howev- er, by week 26 the pressure lowering was at about 6 to 8 mm Hg, de- pending upon the bimatoprost SR concentration, he noted. Currently, of the sustained-re- lease technology, Dr. Aref views the bimatoprost SR implant as poten- tially holding the greatest promise. "The reason is that even though it requires an injection into the eye and therefore carries slightly higher risk than the punctal plugs or the ring, it's efficacious for a longer peri- od of time," Dr. Aref said. "With the plugs or with the ring, they are only efficacious for a 3-month period, then the patient is going to have to come back into the office." This is something that is likely to create a great amount of stress on patient care, he thinks. Also, both the ring and the plugs can become dislodged, Dr. Aref pointed out. "With the ring, most of the time patients realize that it has been dislodged and they can notify their physician," he said. "But with the punctal plug, there is a chance that the device can become dislodged and the patient wouldn't even know." Still, with these external devices, the risk of complications is low, and they are often readily reversible. For example, if the wrong-sized ring is placed and causes discomfort or irritation, this can be removed and resized, Dr. Aref explained. He is optimistic about the appeal of the sustained-release approach for patients. "I think that patients who have glaucoma are understandably anxious and scared about their disease because of the potential for blindness and at the same time cognizant that they may Delivering continued from page 72 TO VIEW THE CURRENT AND PAST ISSUES OF EYEWORLD, VISIT DIGITAL.EYEWORLD.ORG

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