Alimera Sciences: Addressing DME with Persistent Microdose Therapy
Alimera Sciences is focused on the commercialization of ILUVIEN (fluocinolone acetonide intravitreal implant) for diabetic macular edema (DME), which received FDA approval in 2014. The product is currently marketed in the US and three European countries, and is approved in 14 others. Alimera is gaining traction in the market, with over 6,000 eyes treated to date, and 66% sequential revenue growth in the most recent quarter.
At the OIS@ASRS Retina Company Showcase, Dan Myers, CEO, noted that Alimera’s treatment philosophy for DME is to provide persistent, sustained-release, microdose therapy for a chronic disease. Anti-VEGF injections are generally effective in DME patients, but DME is more multi-factorial than AMD (age-related macular degeneration) and many patients benefit from combination therapy that includes steroids.
“INUVIEN is not your father’s steroid,” said Myers, pointing out that it is 1,000 times lower in its daily dose than other steroids that are approved for ocular injection. There has never been a great debate regarding the efficacy of steroids in treating DME, according to Myers, and Alimera’s clinical trials showed efficacy out to three years. “The question has always been, can we balance the [intraocular pressure] risk associated with [glaucoma] filtration surgery?” To mitigate this risk, the FDA-approved indication for ILUVIEN requires a previous course of corticosteroids without a clinically significant rise in IOP. Myers noted that in Europe, where there is no such limitation, clinical data on over 600 eyes with up to two years of follow-up show “virtually zero IOP surgery in real-world data. So we’ve clearly learned a lot about the disease and how to treat these patients.”
Regarding future indications for ILUVIEN, there has been productive dialog this year with the FDA regarding possible clinical trials addressing retinal vein occlusion (RVO) and non-proliferative diabetic retinopathy (DR).
Dan Myers is the Co-Founder, President, and CEO of Alimera Sciences, Inc.
Dan Myers: So Alimera Sciences is a company based in Atlanta, Georgia. We’re 160 employees, 60 of which are based in Europe and the other hundred here in the US. And we’re dedicated to the back of the eye, specifically retina disease, and our product Iluvien for treating DME. And our thesis pretty straightforward: for a disease like DME, that’s a persistent, long term, chronic disease, why would we not consider a long term micro dose system much like the diabetic has in an insulin pump? Just a constant daily does, in our case, Iluvien, fluocinolone acetonide, .2 micrograms per day. We know that anti-VEGFs work. Obviously they’ve been a godsend for many patients in AMD, but they’re very specific in the [mediator?] they prevent, obviously VEGF. We believe the data is beginning to show, and we’ve got a lot of evidence, that DME is a much more multi-factorial disease, much more complicated that AMD, and perhaps with these mediators like we see here on the screen, other cytokines, the steroids that have a broader approach to these mediators could be considered as a place to go when you’re thinking about DME. And I think you’re going to see, and I think the jury is no longer out, that steroids will have a much more prominent role along with the anti-VEGFs in treating diabetic macular edema. We know that anti-VEGF responders are lower in DME, protocol T, when we just saw that a couple years ago at AAO. Of the three anti-VEGFs arms, between 36 and 56% of those patients had to go into rescue therapy. In protocol I, we saw that after 3 injections, 38% of the anti-VEGF patients did not even get 5 lines or better throughout the course of the trial. So this is not to bash anti-VEGF; they’re wonderful drugs. But in DME, we’re going to have to think broader. And I think when you think about steroids, I like to say that Iluvien is not your father’s steroid. If you look at these, of the 3 drugs that are approved and indicated for the treatment of DME, and Iluvien is 1000 times lower in its daily dose than what currently can be administered in the eye. So again, this concept of long term, sustained release micro dosing over 36 months. I don’t think there’s ever been a great debate did we think steroids would be efficacious. I don’t think the surprise when our trial was approved as well as the Ozurdex trial. I mean I think we know that steroids work. For our case, out to three years, and a patient receives almost up to 30% 3 line gainers through that period of time. The question has always been can we balance the IOP risk associated with filtration surgery. And that’s why, when I reported last year at our launch, the FDA agreed with an indication that required a previous course of corticosteroids without a clinically significant rise in IOP. In other words, trying to filter out these high responders who might move on to filtration surgery. Now when you look at the indication and the side effect profile, and then go to our Fame Trial data sets, so these were the actual patient in our Fame trial, 956 patients, and you look at those patients who met that indication, there were literally zero filtration surgeries. So we think we’ve come a long way in what we know about the use of steroids in the eye. And we’ve mitigated this issue that sometimes can stop a doctor from trialing Iluvien. More importantly, in Europe, we don’t have the prior course of corticosteroid label indication. And so we now have 3000 patients in the EU, some with as long as 2 years-worth of follow up, a few now three, with no prior course of corticosteroid. And we’ve had these two cohorts were presented at the Royal College of Ophthalmology in May. And if you notice, in both trials, the numbers are large: 290 patients, 328. Two years-worth of follow up. And if you go to the far right there, virtually zero IOP surgery in real world data with these patients. So we clearly learned a lot about the disease and about how to treat these patients since our trial ten years ago. I think that’s starting to be manifested in the commercial status that many of you know from prior presentations. We have approval in 17 countries in Europe, 3 of which we’re now marketing and commercially available, and also in the US. We have now licensing deals in Israel, Middle East, Italy, Australia, and Canada. We expect to see sales in Italy and the Middle East either later this year or into next year. So you’ll start seeing some geographical expansion. I’m happy that our quarterly report that we just gave, our earnings call on Thursday, we were able to show that the traction is really beginning to occur. Sixty-six percent growth quarter over quarter and total sales approaching almost our first $10 million quarter. If you look at in the US, since it’s a buy and bill model, one of the key things we look for is account growth. Obviously, if a doctor is going to have to buy their product from us, they need to set up an account. We have 61 new accounts in the first quarter followed by 50 new accounts in second quarter. So we’re really starting to see the interest in the trial of Iluvien beginning to take shape in the US. Breaking our sales down by geography very quickly, you can see 7.2 million, a record quarter for us. And key on that lower right is that the customers are – many customers are no longer filing benefit investigations, which tells me that the J code we got in January is really starting to take effect, and doctors are not worried about reimbursement as much. I mentioned about the growth in Europe. Germany, 5 consecutive quarters now. We’re very proud of what the team has done over there. I’m always asked what is next, where you go with Iluvien. I’m happy to report we’ve had some very good dialog with FDA in the last 6 months. We think we now know a path forward to either pursue retinal vein occlusion or non-prolific diabetic retinopathy with one trial. We’ll be looking at the rest of the year and making decisions on that in 2017. So at the end of the day, we think we’re in the right place. We think we’re set up demographically where we eventually have to go when you consider the increasing growth in diabetes – we know that’s growing at almost epidemic proportions, and 75 million baby boomers who have to come through this system over the next 20 years – the idea to keep sticking needles in patient’s eye every month, every 2 months or even every 3 months just doesn’t seem plausible to all patients. So we like where we are; we look forward to giving you updates in the future. Thank you.