Eyeworld

EW CATARACT 41 August 2017 by Rich Daly EyeWorld Contributing Writer pain and inflammation, it was quite effective." There were no treatment-related serious adverse events, and Dexten- za was well tolerated in all clinical trials. No patients experienced any adverse events resulting in study withdrawal. Dr. Talamo noted that although steroids frequently produce IOP spikes, there was only a 7% in- cidence of IOP spikes across the Phase 3 results and no instance was deemed product-related. Steroid-re- lated IOP increases typically take 10 days to 2 weeks to occur, and the ones in the study all occurred in the first days after surgery. Among the 550 patients across the Phase 3 development program for Dextenza, there was one instance of a product- related IOP spike. "Dexamethasone is a fairly potent corticosteroid, so you'd think we would see more IOP spikes," Dr. Talamo said. "But it relates to the sustained release platform and the fact that we get adequate levels of penetration with very little drug." Dr. Talamo credited the differ- ence to the loaded insert providing 10% of the drug exposure that typ- ically occurs over a 4-week taper of steroid drops because Dextenza lacks the "peaks and valleys necessary to get enough penetration with an eye drop." Richard Lindstrom, MD, adjunct professor emeritus, Uni- versity of Minnesota, Minneapolis, will use Dextenza along with a topical NSAID. He plans to use an AC moxifloxacin/dexamethasone/ ketorolac injection and then put in the dexamethasone insert. Dr. Lindstrom expects the insert to be covered by pass through reimbursement for most Medicare patients when it receives regulatory marketing approval, but broad insur- ance coverage will take some time. "I will do what's in the best interest of the patient. They will have the choice to go buy drops and take the drops, or they can choose something I can put in at the time of surgery and with pass through reimbursement, it will be absolutely free," Dr. Lindstrom said in a panel discussion at the 2017 ASCRS•ASOA Symposium & Congress. In a 45-ophthalmologist survey by Ocular Therapeutix, 90% said that even though topical corticoste- roids are a single course of therapy, they are complicated enough and compliance is enough of an issue right after cataract and other eye surgeries that they thought Dexten- za would be a meaningful improve- ment. Additionally, about 80% of surveyed ophthalmologists thought if it met good use acceptance— people found it easy to use and reimbursement was easy to obtain— then it could be the new standard perioperative steroid therapy. "Among perceived benefits were the facts that there are no preserva- tives, that there's a low incidence of IOP spikes, and that there's an ability to control the dosing," Dr. Talamo said. A key question remains whether the new delivery vehicle will outper- form other clinical approaches. "Any time a new therapy comes out and the clinical development program runs against placebo, the question is, 'How does this compare to my stan- dard of care?'" Dr. Talamo said. Dr. Talamo said the comparative results remain an open question and that physicians are going to have to decide based on their own results. "Our clinical development program suggests it performs similarly to the other on-label topical steroids used after cataract surgery. But not until it is on the market are people going to get that level of comfort." EW Editors' note: Dr. Lindstrom has finan- cial interests with Ocular Therapeutix. Dr. Talamo is the former chief medical officer of Ocular Therapeutix. Contact information Ocular Therapeutix: medicalaffairs@ocutx.com Lindstrom: rllindstrom@mneye.com Sustained release insert provides pain, inflammation benefits A new kind of vehicle for postop delivery of cortico- steroids showed promise in its Phase 3 clinical trials. The double-blind study of 438 patients randomized to a control receiving a placebo found punctal plugs loaded with dexa- methasone (Dextenza, Ocular Thera- peutix, Bedford, Massachusetts) and implanted perioperatively provided superior absence of anterior cham- ber (AC) cells (a sign of inflamma- tion) at 2 weeks and less pain 8 days postop to cataract surgery. Topical NSAIDs were not used. The statistically superior results included a finding that more than 52% of patients receiving Dextenza had no AC cells at 14 days postop, compared to 31.1% of placebo sub- jects. Additionally, 79% of Dextenza patients reported no pain 8 days postop, compared to 61.3% of the placebo recipients, according to data reported at the 2017 ASCRS•ASOA Symposium & Congress. "When you look across the Phase 3 trial, it works as well as a topical steroid without the extra burden of patient compliance and without the load of preservatives; the physician can control what is given and when it is given," said Jonathan Talamo, MD, former chief medical officer of Ocular Therapeu- tix. "The data shows that for postop Stephen Kim, MD, a retinal special- ist, who claimed that nonsteroidals were no longer that helpful in cata- ract surgery. 1 "But the original paper only addressed the prevention of CME," Dr. Donaldson said, adding that this paper claimed that since cataract surgery has improved sig- nificantly since the days of extracap- sular surgery, now with lower and lower incidents of CME, this is most likely no longer necessary. But she pointed out that NSAIDs also help with pupil dilation and pain control. "There's not a lot of pain with cataract surgery, but NSAIDs are pain relievers and this is the FDA approved utility for NSAIDs in cataract surgery," Dr. Donaldson said. "It's a nonsteroidal, thus it deceases prostaglandin release." For patients undergoing fem- tosecond laser-assisted cataract surgery (FLACS), NSAID use can be particularly important. "We know those patients have higher levels of prostaglandins in the anterior chamber and are more likely to have pupillary miosis," she said. "I find that pretreatment with NSAIDs is extremely helpful with FLACS." Using Omidria (phenylephrine/ ketorolac, Omeros, Seattle) doesn't help with pupil dilation for the laser portion of the FLACS procedure since the femtosecond laser cuts the flap before the Omidria is in the eye, Dr. Donaldson said. "Only the preoperative dosing would help with femtosecond patients to make sure that their pupil is large enough for the laser portion," she said, adding that without this, the surgery may become more challenging. However, Omidria is very helpful in maintain- ing pupillary dilation throughout the intraocular/phacoemulsification portion of the procedure. Dr. Miller said that NSAIDs have a certain role to play. "I think the pharmaceutical industry has done a great job at convincing ophthalmol- ogists of the overwhelming benefits of trade name NSAIDs, but the litera- ture doesn't support their claims," he said. "I think a bit of reanalysis is appropriate." Dr. Devgan is looking forward to a time when NSAIDs can be injected into the eye and left in a depot like steroids. "I think a future advance would be to have an NSAID depot injection or a pellet we can put in that will slowly elute the drug over the course of the month postop," Dr. Devgan said. EW Reference 1. Kim SJ, et al. Routine use of nonsteroidal anti-inflammatory drugs with corticosteroids in cataract surgery: Beneficial or redundant? Ophthalmology. 2016;123:444–6. Editors' note: Dr. Devgan has financial interests with Alcon. Dr. Donaldson has financial interests with Alcon, Bausch + Lomb, Johnson & Johnson Vision (Santa Ana, California), Sun Pharmaceutical, and Omeros. Dr. Miller has financial in- terests with Alcon and Johnson & John- son Vision. Dr. Charles has no financial interests related to his comments. Contact information Charles: scharles@att.net Devgan: devgan@gmail.com Donaldson: kdonaldson@med.miami.edu Miller: kmiller@ucla.edu Update continued from page 40

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