Alimera Sciences (ALIM) Announces Publication of Phase 4 PALADIN Study with ILUVIEN
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Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be of invaluable value to patients, physicians and partners concerned with retinal health and the maintenance of ‘better vision for longer, today announced that the 3-year results of the PALADIN study have been published in the peer-reviewed journal Ophthalmology.
The results of this study show that patients with diabetic macular edema (DME) who received a single dose of the extended-release implant ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg demonstrated improvements statistically of best corrected visual acuity, central subfield thickness and treatment load at 36 months. Patient treatment frequency in the PALADIN study was reduced by 70.5%, from a median of 3.4 treatments per year in the 36 months prior to ILUVIEN injection to a median of 1.0 treatment per year in the 36 months following the injection of ILUVIEN. Additionally, 2.97% of eyes required IOP lowering surgery, only half of which were due to steroid-induced ocular hypertension following administration of ILUVIEN according to the US label. This compares favorably to 4.8% in the pivotal FAME studies. For the full publication, click Right here.
A post hoc analysis of PALADIN data over 36 months found that patients who received ≤ 6 treatments for DME prior to ILUVIEN administration had significantly greater gains in visual acuity compared to patients who received > 6 treatments before receiving ILUVIEN (5.70 letters, P=.0048 against 1.78 letters, P = .8337). These results suggest that using ILUVIEN earlier in a DME treatment algorithm could lead to more desirable visual acuity outcomes.
“We are very pleased to see confirmation from the PALADIN study that the risk of intraocular pressure side effects can be effectively mitigated when ILUVIEN is used according to our US FDA label,” said Rick Eiswirth, President and CEO of Alimera. “Additionally, we are pleased that the PALADIN study provides another set of data demonstrating the ability of ILUVIEN to improve visual acuity with fewer therapeutic interventions and further supports our NEW DAY study hypothesis.”
The PALADIN study was a prospective, phase 4, open-label, observational study conducted over 36 months at 41 sites across the United States. The study was designed and developed to confirm the benefit of using prior corticosteroid therapy as indicated in the ILUVIEN US label, to mitigate the risk of uncontrolled IOP elevation. The researchers recruited 202 eyes from 159 patients with DME who had previously received corticosteroid therapy without a clinically significant increase in IOP. All eyes were treated with ILUVIEN and patients were followed for up to 36 months.
“The 3-year results of the PALADIN study demonstrate the ability of ILUVIEN to safely and effectively improve visual acuity and retinal anatomy while reducing the recurrence of edema, as evidenced by decreased treatment burden in patients with DME,” said Michael Singer, MD, Clinical Professor of Ophthalmology, University of Texas Health Science Center, San Antonio, and Director of Clinical Research Medical Center Ophthalmology, San Antonio, Texas. “This is particularly important for the diabetic population. Many diabetics are actively working and would otherwise be under a high treatment load of injections that are currently required with anti-vegf therapy alone. results.
Primary outcomes included changes in IOP and interventions to manage IOP elevations; secondary outcomes examined visual, anatomical, and treatment burden outcomes. Among the findings at 36 months:
- Mean best corrected visual acuity increased by 3.61 letters (P = 0.0222) from baseline.
- The average thickness of the central subfield decreased by 60.69 µm (P
- Patients received an average of 1.0 treatments per year after receiving ILUVIEN. During the 36-month period immediately preceding administration of ILUVIEN, patients received an average of 3.4 treatments per year. Thus, the ILUVIEN treatment resulted in a 70.5% reduction in treatment load.
- Surgery to treat elevated IOP occurred in 2.97% of eyes; only 1.49% of patients were operated on due to steroid-related IOP elevation, with the remaining cases of IOP elevation primarily attributed to neovascular glaucoma.
- An IOP response ≤ 25 mm Hg after steroid challenge predicted a similar outcome after ILUVIEN treatment at last visit in 96.9% of eyes.
- Mean IOP remained stable throughout the study, and IOP increases of >30 mm Hg were observed in only 10.9% of eyes. The increases in IOP that occurred were considered manageable with standard treatments, according to the study authors.
Full details of the study are available here.
About Diabetic Macular Edema (DME)
DME, the leading cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the leakage of blood vessels associated with diabetic retinopathy leads to swelling of the macula, it is called DME. The onset of DME is painless and may not be noticed by the patient until it manifests as central blurred vision or acute vision loss. The severity of this blurring can vary from mild to profound vision loss. The Wisconsin Epidemiological Study of Diabetic Retinopathy found that over a 10-year period, approximately 19% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.