Rick Eiswirth is the president and CEO of Alimera, a global pharmaceutical company that markets both ILUVIEN and YUTIQ. ILUVIEN treats patients with diabetic macular edema (DME). YUTIQ treats chronic non-infectious uveitis affecting the posterior segment of the eye. Alimera is conducting studies on both drugs. Mr. Eiswirth has held several executive positions with Alimera since joining the company in 2005.
Ophthalmology Management: Last year, Alimera acquired the US commercial rights to YUTIQ from EyePoint Pharmaceuticals. Can you tell us more about this?
Rick Eiswirth: One of our goals is to make Alimera the “place to be in retina.” As such, we want to build our company around the retina specialist and to have multiple products available to them and their patients. Acquiring YUTIQ (fluocinolone acetonide intravitreal insert) 0.18 mg was an important first step toward that goal, because it’s a very similar asset to ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg.
For historical reasons, the commercial rights to uveitis in the United States were separated between two companies, and this was an opportunity to bring those together. We’ve had the ability to market ILUVIEN with the uveitis indication in Europe for quite some time, but we didn’t previously have those rights in the United States. Now, we have the ability to market the same underlying technology for both DME and uveitis on a global basis, except for China.
Additionally, the acquisition of YUTIQ allows us to continue to invest more into the brands, to engage with physicians more, and ultimately look for other products or other indications that we could commercialize with the assets that we have.
OM: Earlier this year, Alimera completed recruitment for its Phase 4 Synchronicity study. Can you give us an update?
RE: The Synchronicity study is being done across a broader range of general retina specialists, not just uveitis specialists. The study will track and look at specific types of uveitis.
The hope is that Synchronicity provides more YUTIQ clinical data from a broader number of doctors, enabling more physicians to discuss where the drug should work longer term. We expect to have an interim readout at 6 months in the second half of 2024, then 18 months of follow up and another readout in late 2025.
OM: The first patient has been randomized in a study of ILUVIEN or faricimab (6.0 mg) injections vs observation for the prevention of visual acuity loss due to radiation retinopathy. Can you give us an update?
RE: The study, run by the DRCR Retina Network, plans to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy. It will assess the development of macular edema and associated long-term visual acuity effects of consistent and continuous release of corticosteroid or repeated injections of anti-VEGF. Treatment will be initiated near the time of radiation therapy and be compared to observation until macular edema develops in patients at risk for radiation retinopathy.
We think it’s an exciting study for us to be involved in — to have that critical mass where we can work with the DRCR Retina Network and engage them to look at additional utilization oflong-term, low-dose steroids in the eye. We think it makes perfect sense now that we have the uveitis indication.
OM: Can you discuss your NEW DAY study to evaluate ILUVIEN as a first-line baseline therapy for DME?
RE: Our most impactful clinical study as we move forward is the NEW DAY study, a head-to-head clinical study of ILUVIEN vs aflibercept as first-line baseline therapy in the treatment of DME. This study is looking at newly diagnosed diabetic patients with the loading dose of aflibercept in one arm and ILUVIEN in the other arm. We’re looking to significantly reduce the recurrence of disease, and as a result, keep the disease under greater control in order to provide better visual acuity results over time.
We have observed across multiple cohorts that utilizing ILUVIEN earlier does lead to better control of edema in diabetic patients, as well as better visual acuity results. We are very excited about the prospective outcomes of this study and are looking forward to sharing those results early next year. OM
