Once cataract surgery is complete, patients are prescribed various eye drops to manage postoperative inflammation. This fall at MillennialEYE Live, four surgeons talked about how to integrate DEXYCU, the first intracameral steroid approved for the treatment of postoperative inflammation, into cataract surgery protocols.
Robert J. Weinstock, MD: I’m excited to be with three very innovative and successful ophthalmologists to discuss new modalities for delivering medications to the eye during cataract surgery. There is now available an intracameral steroid suspension that is FDA approved to treat postoperative inflammation. This medication, DEXYCU (EyePoint Pharmaceuticals), is a 9% dexamethasone suspension that can be injected at the end of a cataract surgery case.
All four of us have had some early experience with this technology. I’d like us to share the things we’ve learned, including how it’s impacted our practices, how our peers can be successful with DEXYCU, and how it’s now becoming our steroid of choice after cataract surgery. What do you think is the standard of care for most cataract surgeons? How many different medications are we typically prescribing to our cataract patients?
Jonathan D. Solomon, MD: I think everybody has their own protocol, but the vast majority of surgeons prescribe three different medications–a nonsteroidal anti-inflammatory drug (NSAID), a steroid, and an antibiotic. Some might prescribe two drops where one is a combination.
Dr. Weinstock: Now with DEXYCU, we have a well-known medication, dexamethasone, in an FDA-approved intracameral form. It has a manufacturing process whose safety and reliability we can hang our hat on. Does this change things? Does it help your comfort level for doing injections at the end of surgery?
Mitchell A. Jackson, MD: Having an FDA-approved product is a no-brainer. Because it’s FDA-approved, we know the clinical trial data behind it. We can bring it in easily. It’s really the first option for intracameral injection that we’ve had in our facility. Our facility only allows FDA-approved—and no compounded—products to be used intracamerally.
Cathleen M. McCabe, MD: Similarly, we’ve had a longstanding commitment to using only FDA-approved products. DEXYCU gives us an alternative to steroid drops for the eye to get the medication it needs after surgery.
Dr. Weinstock: With DEXYCU, we’re delivering a 9% dexamethasone suspension into the eye, behind the iris, at the end of cataract surgery. What do you think about that concept? How will it affect patients long term? Do we need to choose the right candidates?
Dr. Jackson: I like this product for my cataract patients. There will always be postoperative inflammation—more so when patients have very dense cataracts and I have a limited view of the retina. By adding a steroid in the eye for sustained release, I know they’re getting the right amount of medicine for the right duration.
Dr. Weinstock: We are all trained to automate what we do. I follow the same protocol and use DEXYCU for all cataract patients. When all patients get the same thing, the staff gets continuity and there’s less opportunity for error. Things run more smoothly.
Dr. Weinstock: I think we all agree that in most cases, steroids are still the standard of care in cataract surgery, but we don’t want some of the side effects. Are you worried about any issues with pressure and corneal edema from putting this small dose of dexamethasone suspension inside the eye at the end of surgery?
Dr. McCabe: It’s just like we would taper our steroid drops. It naturally tapers the dose.
Dr. Weinstock: We notice that this medication tends to diffuse into the eye and disappear. That little sphere of dexamethasone gets smaller and smaller over the first week to 10 days, dissolving away slowly.
How DEXYCU Is Delivered
Dr. Weinstock: Let’s discuss the delivery of DEXYCU in terms of what we do in the operating room and how we integrate this into the flow of surgery. DEXYCU comes in a prepackaged kit. Either the surgeon or a scrub technician can get it ready for surgery. It allows us to consistently deliver the right amount of product behind the iris at the end of surgery.
I’m sure everybody’s technique is a little bit different. What has your experience been so far? Does using DEXYCU require more time or pose any challenges for your staff?
Dr. Solomon: There was a bit of a learning curve. You can go through either your paracentesis or your main incision, or even make a separate paracentesis. I go through the main incision. If there happens to be a little bit of shallowing of the anterior chamber, I’m not bothered by that because I like to move relatively quickly. Using the 25-gauge cannula, I place DEXYCU right behind the iris, pushing the plunger very rapidly, and then removing the cannula from the eye. Next, I reinflate the anterior chamber with my antibiotic as a means to bring it back up to what I’d consider to be a normal physiologic state.
Dr. Weinstock: That’s a perfect technique. It’s exactly how I started doing it as well. For me, there was a little bit of a learning curve because DEXYCU sometimes wants to stick to the end of the 25-gauge cannula. I need to brush it against the bottom of the iris, the capsule, or the lens to grab it off the tip of the cannula.
Dr. McCabe: Sometimes there is a little bit of the DEXYCU coating the end of the cannula that can cause the spherule to cling to the cannula. I wipe that off on the conjunctiva at the entrance to the paracentesis when I’m about to enter the eye. This technique has been helpful in more easily disengaging DEXYCU from the cannula.
Another pearl: Before I’m ready to put DEXYCU in the anterior chamber, I like to hydrate my incision. I don’t want to hydrate after I put it in because I’m trying to minimize how much fluid I put in the eye. I leave the eye a little firmer than I want it to be because I know I’m going to have some egress of balanced salt solution as I go in. I use a paracentesis, which also helps to minimize fluid loss. I place DEXYCU inferior in the capsular bag, just distal to the optic. I use the edge of the optic to scrape off the little spherule, which helps it stay put without moving into the inferior angle. This approach has been very reliable for me.
Dr. Jackson: I have the scrub technician start to prepare the DEXYCU while I’m doing irrigation and aspiration of the viscoelastic after IOL implantation. I like to hydrate the main incision and go through my paracentesis site, placing the DEXYCU posterior to the iris and under the edge of the anterior capsule-IOL optic junction. Then I completely hydrate and seal the anterior chamber paracentesis side incision, and we’re done.
Dr. Weinstock: I think it’s important to know that it’s a very forgiving delivery. Like anything else, delivery is not going to be perfect every single time, but the medication is still going to work just fine. If you go in through the main wound and put DEXYCU under the iris and the eye collapses, the little spherule can come up into the anterior chamber like an air bubble, but we’ve found from early experience that the eye will do fine if that happens. If it drops down into the angle or sticks to the optic of the IOL close to the cornea, it goes away. If you see the DEXYCU break into multiple smaller spheres, that does not affect the outcomes. Even if we see a bit of localized corneal edema for a day or 2, like we would see after a dense cataract removal, the endothelial pump will clear the edema. So, I’ve noticed the same things, and like Dr. McCabe, I tend to go through the paracentesis. I make sure that the eye is well sealed, and I gently go in and put it right in the bag, right at the junction of the haptic and the optic, and it does kind of stick to it there. So, even if the chamber does collapse, the stickiness wants to keep it there.
Dr. McCabe: You might be concerned when you first see that there’s a little residual medication remaining on the optic, but it has not been a concern for us.
Dr. Weinstock: That’s a good point, because we want to educate our referring doctors and any others who might see the patient in the postoperative period. To the uninitiated, it might look like a foreign body or an infection. We tell them that if they see this, it is likely just residual medication that will disappear over time.
Dr. McCabe: Absolutely. It can be reassuring to referring doctors and, ultimately, the patient, if we offer a few different pictures that show what it looks like and where it’s typically located.
Dr. Jackson: Right, because patients might see it. I always tell patients that if they see the medication, that’s a good thing. They know that the medicine is in the eye, so it kind of reassures them. On the other hand, for the referring doctors, we really need to educate them, so they don’t think it’s an adverse event.
Dr. Weinstock: Let’s talk about the results you’ve seen using DEXYCU in cataract surgery. In the FDA phase 3 pivotal trial, the cumulative percentage of subjects receiving rescue medication of ocular steroid or NSAID by day 30 was significantly lower in the DEXYCU treatment group (20%; n = 31/156) compared to placebo (54%; n = 43/80). Not only was that significant, but it also raised the confidence of surgeons.
Dr. McCabe: This is the critical thing, right? We want a steroid to control anterior chamber inflammation in our patients, and in the FDA trial, three times more patients were clear at day 8: 60% (n = 94/156) versus 20% (n = 16/80) with placebo. So, we know that it’s effective. We can reduce the need for rescue medication such as ocular steroids or NSAIDs and have confidence that DEXYCU is going to do the job it needs to do.
Dr. Jackson: And the A/C clearing numbers you mention were achieved without an NSAID onboard, so they show the efficacy of DEXYCU alone. That’s huge for just a steroid. A lot of us use an NSAID as well, which should further reduce inflammation.
Dr. Weinstock: What do you think about how long DEXYCU remains in the eye? Are patients coming back a few weeks later with a red eye? Do they need any additional medications or more NSAIDS than you think they normally would?
Dr. McCabe: We haven’t seen patients return with a red eye. That said, using this medication alone is not a cookie-cutter approach for every patient. We tailor medication to everyone’s individual needs, which may mean we add medications later in the treatment profile or extend the profile if the patient needs it. For example, if I know a patient has a history of chronic uveitis, I use DEXYCU, but because it likely will not still have an anti-inflammatory effect after 30 days, I might use a topical steroid at that point. I can use DEXYCU with other medications as a ‘belt and suspenders’ approach.
Dr. Weinstock: That’s a good point. We’re putting a steroid in the eye, but a high-risk patient like someone with diabetes or a history of macular edema may do best, if we prescribe a topical steroid as well, as long as we check the pressure and watch for complications. I would say it is visibly still present at one week, minimally. I like the way it slowly dissolves because we get verification and peace of mind that it’s hanging around, getting the patient through that postoperative period.
Dr. Jackson: I’ve seen it remain visible all the way to 30 days in a few patients. It’s slow release, and it’s still working.
Dr. McCabe: I don’t necessarily dilate patients at every visit, so if I put it far enough in the bag peripherally, I don’t see it. Nevertheless, I know it’s still there because the proof is in how the patients are doing. They have no anterior segment flare, so I know that they’re controlled and I don’t have to worry.
Dr. Weinstock: I still prefer to use a topical NSAID with DEXYCU because I think it offers some added comfort for postoperative pain and reduces foreign body sensation. I also think it’s important to control inflammation in both pathways. Until we have an intracameral NSAID, do you think that surgeons will continue to use an NSAID along with DEXYCU?
Dr. Solomon: I do. That certainly is going to be my means of management at this point. I don’t think we’ve seen inflammation disappear with any single medication, so we will continue to pair it with an NSAID postoperatively.
Dr. McCabe: I do the same. I think the nice thing about NSAIDs is that they usually require fewer drops per day, so they’re a little bit easier for patients to take. There’s no complicated tapering schedule like we have with topical steroids.
Dr. Weinstock: This has been really helpful. I appreciate your candid comments and your educational communication about DEXYCU, how to use it, and how to integrate it into your practice. I’m sure we’re going to learn a lot more about this product, and it helps to hear from innovative surgeons who are willing to break new ground.
Click here for full Prescribing Information for DEXYCU.