The following transcript has been edited for clarity.
Diana V. Do, MD: Hi, I'm joined by Michael A. Singer, MD. Tell us about your exciting new data on steroids and sustained release for the treatment of retinal vascular diseases.
Michael A. Singer, MD: Diana, it’s always great talking to you. I’m thrilled to represent the NEW DAY trial, explaining the use of the fluocinolone acetonide intravitreal implant (Iluvien; ANI Pharmaceuticals) vs aflibercept (Eylea; Regeneron) in a head-to-head trial. Now, initially what we found was that there were fewer injections in terms of supplementation needed in the fluocinolone arm, but it didn't meet statistical significance. But what you really care about is how long is this from the last [injection]? That was highly statistically significant. And in terms of optical coherence tomography (OCT) thickness, when you stop giving monthly anti-VEGF injections the OCT bounced up and down, like we all know, but Iluvien did very well.
One of the things that keeps everybody up at night is intraocular pressure (IOP). So I spent a lot of time looking at IOP and trying to break it into 1) when it occurs and 2) how it affects. And what we realized is that essentially, IOP over 25 mmHg goes into buckets—a lot of people at 1 month, 3 months, 6 months, 12 months. So we basically recommend giving follow-up every 3 months.
And then this time, new late-breaking data called the OCT retinal nerve fiber layer (RNFL), which we looked at the OCT RNFL and it’s an interesting data set. Three patients actually had optic nerve edema when they came in. So their OCT was greater than 100 µm when you look at RNFL. So 2 out of 3 actually went back to baseline because of the use of fluocinolone.
And then essentially looking at people who had RNFL measurements done, most of them stayed within their own little zone and their color. Essentially the only people that didn't go within their color, 2 or 3 of them basically had a 6 µm change, tiny amounts. And then overall, we look at the whole process, the positive predictive value of essentially being 8 µm difference was 92%. So really the safety was really a big deal, but when it comes down to it, all that worry about IOP doesn’t translate to significant optic nerve damage. And now that we know about the nerve damage and we know about the fact that we can give you recommendations on when to follow people, we've tried to demystify this big black box called steroids.
Dr. Do: That's great. And what about incisional glaucoma surgery? Did any eyes in the NEW DAY study require that?
Dr. Singer: So only 1.9% of people had incisional surgery and the numbers were very small. Essentially we looked at really small numbers of people who had IOP over 35 mmHg. Most people did very well. Positive predictive value of having an IOP over 25 mmHg by the end of the trial literally was 94%. So yeah, vast majority of people it’s worked very well.
Dr. Do: Great. Well, thank you for that update on the fluocinolone implant and we look forward to talking with you at future meetings.
Dr. Singer: Thanks for having me. RP
