EyeWorld Asia-Pacific June 2016 Issue

63 EWAP PHARMACEUTICALS June 2016 triamcinolone versus topical combination therapy.” Richard Lewis, MD , Sacramento Eye Consultants, Sacramento, California, likewise stressed the importance of having studies on the use of intravitreal agents versus drops. He also pointed out that there may be medical-legal considerations with this approach. “There’s always a concern that if you use an intracameral antibiotic and the patient gets endophthalmitis, you could be liable because you didn’t have him or her on drops,” Dr. Lewis said, adding that while he is not aware of a lawsuit, he could imagine an argument that endophthalmitis doesn’t manifest until about 2 days postoperatively. This is usually the result of a wound leak. “One could argue that intracameral antibiotics aren’t sufficient,” he said. There is also the question of whether the triamcinolone injected steroid is sufficient. “Is it enough steroid? Is it lasting 2–3 weeks to prevent CME and other inflammatory problems? That has not been studied,” he said. Sustained-release plug Another option currently being studied is use of a punctal plug filled with dexamethasone, which is put in the puncta of the eyelid at the time of cataract surgery, according to Shamik Bafna, MD , Cleveland Eye Clinic, Cleveland. “Once you finish removing the cataract and have placed the lens, you dilate the punctum and place the plug in position,” he said. “The plug will elute the active ingredients over the next 4 weeks.” One of the key features of the dexamethasone punctal plug is a fluorescent component. “Even though the patient can’t see the plug, it’s possible to shine a cobalt blue light over the eye to ensure that it hasn’t migrated or left the eyelid,” Dr. Bafna said, adding that “after the medication has gone out of the plug, the device is reabsorbed and extrudes out of the basal lacrimal system.” In Dr. Bafna’s view, the dexamethasone punctal plug has several advantages over traditional postoperative drops. “I think the biggest advantage is one of compliance in the sense that when patients have to use drops after cataract surgery, there’s always the question of whether they are using drops appropriately or not,” he said. After surgery, many times patients’ eyes appear fine to them and they may prematurely stop taking the drops on their own. Another factor for some may be cost, with patients wondering whether they need to spend the money for drops. Another big factor in terms of steroid medication is the fact that many times this comes in the form of a suspension. “If you don’t shake the bottle at least 20 to 30 times, you won’t have an appropriate dosage,” Dr. Bafna said. “The benefit of the plug is there will be a consistent dose released for the next 3–4 weeks, and the patient won’t have to think about it.” He has found that it’s a convenience for the patients who took part in the FDA phase 3A and 3B study. “In the study, we were only allowed to enroll one eye, and many of those patients complained that they had to use drops in their second eye— they wished that we could have put a plug in their other eye as well,” Dr. Bafna said. In the phase 3A study for which Dr. Bafna was an investigator, results were clear- cut. “We found that there was a statistically significant improvement in both pain and inflammation with the plug compared to placebo,” he said. In the phase 3B study, they determined that when it came to pain, there was statistical significance; in terms of inflammation, while the plug performed equally well, two patients in the placebo group did better than expected. As a result, statistical significance was not achieved for inflammation in the phase 3B trial. “Those two patients were taking systemic, oral anti-inflammatory medication, and the thought process is that this is the reason those patients ended up doing better,” Dr. Bafna said, adding that the company is planning to resubmit another study to the FDA using tighter exclusion criteria. The dexamethasone punctal plug is something that Dr. Bafna envisions could be utilized for the vast majority of patients. For others, it could be used in conjunction with other medication such as nonsteroidal anti- inflammatories to prevent CME. “If a patient had diabetic retinopathy at the time of cataract surgery, [we may] place the plug but may also have the patient use a nonsteroidal drop at the same time to try to prevent CME,” Dr. Bafna said. “But the vast majority of cataract patients could do fine with the plug alone.” “The hope is in 2016 the product will be available,” Dr. Bafna said. Going forward, he thinks that different medication- eluting plugs can be utilized for other ocular indications such as glaucoma or even seasonal allergies. “It’s possible that we could deliver that same medication through the plug and help in a compliance situation where they don’t have to use drops on a daily basis,” he concluded. EWAP References 1. Gustafson T. Transitional pass-through payments. ASC Focus . September 2015;8–9. 2. Chang DF, et al. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology . 2014;121:829–834. 3. Chang DF, et al. Risk factors for steroid response among cataract patients. J Cataract Refract Surg . 2011;37:675–681. Editors’ note: Dr. Bafna has financial interests with Ocular Therapeutix. Dr. Chang has no financial interests related to his comments. Dr. Lewis has financial interests with Aerie Pharmaceuticals (Bedminster, NJ), Alcon (Fort Worth, Texas), Allergan (Dublin), and Omeros. Dr. Liegner has financial interests with Imprimis. Dr. Lindstrom has financial interests with Alcon, Abbott Medical Optics (Abbott Park, Illinois), Bausch + Lomb (Bridgewater,NJ), Imprimis, Omeros, and Ocular Therapeutix. Contact information Bafna: drbafna@clevelandeyeclinic.com Chang: dceye@earthlink.net Lewis: rlewismd@pacbell.net Liegner: liegner@embarqmail.com Lindstrom: rllindstrom@mneye.com