Eye Disease of the Year
Julia A. Haller, MD: Hi. I'm Julia Haller, ophthalmologist-in-chief at Wills Eye Hospital. This is a special collaboration between Medscape Ophthalmology and Wills Eye Hospital. With me are my colleagues Dr Carl Regillo, director of our retina service, and Dr Allen Ho, director of retinal research. We are here to recap some of the highlights from the American Academy of Ophthalmology (AAO) meeting and also to look back on this year as well as forward into the horizon, with both a retrospective and an update on what is new in retina. Carl, what sticks in your mind as you look back over this last year and at some of the highlights of the AAO meeting?
Carl D. Regillo, MD: There have been a lot of developments in our field. Once again, it has been a good, exciting year. Diabetic macular edema (DME) is probably the disease of the year in that we have three newly approved drugs. Aflibercept (Eylea®) received US Food and Drug Administration (FDA) approval for DME. We have the dexamethasone intravitreal implant (Ozurdex®) and the fluocinolone acetonide intravitreal implant (Iluvien®), two long-acting steroid devices. These clinical trials have been taking place for a few years, but it really came together with the FDA approval this year.
Dr Haller: Very exciting. What about you, Allen? When you look back, what do you think?
Allen C. Ho, MD: It's very clear that DME has been the showcase for new treatments in retina. We now have different classes of drugs. This is good because DME is a complex disease and doesn't always respond to one class of drug. Having shorter- and longer-term steroid options will be good for our patients.
A Frustrating Lack of Data
Dr Haller: How about that press release[1] at the meeting? It wasn't a podium presentation, but Regeneron put out a press release showing that in the Diabetic Retinopathy Clinical Research Network trial head-to-head comparison of anti-vascular endothelial growth factor (VEGF) agents, aflibercept looked a little better.
Dr Ho: It's just a press release, so we look forward to the full dataset and manuscript. It's no longer typical for the sponsor of a trial to put out a release of information without providing the full dataset. That reflects some old rules.
Dr Haller: It's a conservative strategy.
Dr Ho: In the interim, it leaves doctors and patients in the lurch. We know the magnitude of the difference between the different treatments. Protocol T compared prn (as needed) bevacizumab (Avastin®), aflibercept, and ranibizumab (Lucentis®). We need more information about that.
Dr Regillo: We came out of the AAO meeting saying that the biggest news was not officially at the meeting because it never got to the podium. We would have liked to see more details, for providers and patients, so we have a better sense for whether there are real differences among these three anti-VEGF drugs for treating DME. Instead, we had minimal information from a press release. Stay tuned, because maybe January or February of 2015 will be the timeframe to have some more details.
Wet AMD: Catch It Early
Dr Haller: Was there anything else besides diabetes that sticks in your mind, Allen?
Dr Ho: On the macular degeneration front, we have made tremendous progress in wet age-related macular degeneration (AMD) over the past 7-10 years. On the dry AMD front, we are looking at a variety of different investigational trials for geographic atrophy. I will let Carl speak to that. One of the more interesting things is the whole notion of monitoring at home. We now have some information from Notal Vision™ (St. Louis, Missouri) with the ForeseeHome™ device to monitor patients' vision at home with such a device as a pair of binoculars, wirelessly connected through the Internet, and it showed that patients who converted from dry to wet did much better because they were detected earlier. I like this idea of continuous monitoring at home.
Dr Regillo: Early detection is the key to achieving the best results in AMD. In fact, through this year, we have had several studies that show that when you detect wet AMD when vision is still good (20/40 or better), the chances of keeping the vision at 20/40 or better is very high (>70%). That shows how well our drugs really work and the power of early detection. That is the biggest step forward in identifying these patients and effectively treating them early.
For dry AMD, Allen is right. We are now in the midst of launching phase 3 for the drug lampalizumab for dry AMD. That could indeed be our first and only dry AMD treatment in the future. It will be a big phase 3 definitive study that will tell us whether this drug slows the progression of dry AMD. The phase 2 trial showed some preliminary positive efficacy, and now they will put it to the test in a phase 3 study.
Advances in Advanced Dry AMD
Dr Haller: Speaking of dry AMD, congratulations on your article in TheLancet.[2] Do you want to comment on stem cell therapy?
Dr Regillo: Allen and I and many others in the United States and abroad have been working with stem cell protocols and programs for advanced dry AMD and also with Stargardt disease. Stargardt disease is not all that rare. Its prevalence is estimated to be 1 in 10,000. It's the most common cause of juvenile-onset advanced macular degeneration. We were able to show that we could safely administer stem cell-derived retinal pigment epithelial (RPE) cells—it's an RPE transplant—and deliver it safely, have some controlled growth, and some signal that something positive is happening in patients with advanced dry AMD and advanced dry Stargardt disease. In The Lancet, we published long-term interim results from phase 1. Based on those findings, we are moving quickly into phase 2 trials. Just yesterday, we came away from an investigator meeting to launch a phase 2 trial for the same stem cell line of RPE cells to be used in advanced Stargardt disease and advanced dry AMD.
Dr Haller: Exciting. Allen, they are ringing the bell on Wall Street for Second Sight (Sylmar, California). Any thoughts? You have been very active both in the development and now implementation post-FDA approval.
Dr Ho: It is for patients with the most advanced vision loss owing to retinal degeneration, severe retinitis pigmentosa. Second Sight's Argus® II device is a hardware system composed of a retinal chip implant with 60 microelectrodes, wirelessly associated with a video system camera and processor unit that powers the microelectrode arrays that are placed surgically on the macula. We have had some good success here. It's the beginning of a whole new world of potential therapies for patients with the most severe vision loss.
Can't-Wait Technology
Dr Haller: Was there any new high-tech stuff at the AAO meeting? How about surgery? What are you thinking about optical coherence tomography (OCT) combined with your operating room (OR) scopes? Is that gaining traction?
Dr Regillo: Two things on the surgical front excite me the most. One is intraoperative OCT coupled to the OR microscope. Related to that is an interesting monitor system with which we can better see what is happening in the OR. I am very excited about 27-gauge vitrectomy that was official launched at the AAO meeting. One company, at least, has a system. We will all be dabbling in 27-gauge, ultra-small-incision vitrectomy surgery. It has been very successful going from traditional 20 gauge to 23 gauge and 25 gauge, and now 27 gauge opens up other potential advantages of this type of surgery.
Dr Ho: Of interest, the 27-gauge instrument may be most suited for such complex cases as proliferative diabetic retinopathy with traction retinal detachment. The smaller-gauge probe and mouth cutter opening allow you to get into tissue planes with the cutter alone.
Dr Regillo: It's somewhat counterintuitive. We used to use the smaller instruments in the easier cases because of some flexibility issues in the first-generation instruments, but they have overcome many of the shortcomings of smaller, finer instruments. Now with the way that they function, it is quite impressive. We do our hardest cases with them, and they may be most advantageous for the most challenging proliferative diabetic retinopathy traction detachment type of cases.
Dr Haller: What a great field. So many exciting things are happening. Have we missed anything that anyone wanted to bring up?
Dr Regillo: It is impressive that we are still making strides and further advances on both the surgical and the medical fronts.
Dr Haller: Let's not forget laser. There is a lot of interest in minimally damaging laser. There are some new protocols on the horizon to see whether we can make it just as effective, or more effective, with less collateral damage.
For Wills Eye Hospital, my colleagues, and Medscape Ophthalmology, thank you.
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Cite this: Retina Recap: Year in Review - Medscape - Dec 10, 2014.
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