PALADIN Study Data Presented at the American Society of Retina Specialists Shows That Post-ILUVIEN, the Percentage of Eyes Receiving One Yearly Treatment or Less Increased 3.2-Fold Compared to Pre-ILUVIEN
Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and to maintain better vision longer, announces a data presentation at the American Society of Retina Specialists (ASRS). The presentation demonstrated significant reductions in treatment burden in patients receiving ILUVIEN for Diabetic Macular Edema (DME).
The real-world data from the Phase 4 PALADIN study show that patients receiving one or less total injections per year for their DME after the ILUVIEN injection increased three-fold from prior to the ILUVIEN injection. The data also show that the percent of patients who needed more than four DME treatments per year was reduced by 50%.
The abstract presented by Dr. Victor Gonzalez, lead author, presenter, and Retina Specialist at Valley Retina Institute, analyzed a subset of 83 eyes from Alimera’s PALADIN Study for which the company was able to collect data for 24 months both pre- and post-ILUVIEN injection. For this analysis this subset was divided based on the number of supplemental treatment events (including laser, intravitreal anti-VEGF and steroid) per year before and after receiving ILUVIEN.
“These data demonstrate a significant reduction in treatments in patients with DME after receiving ILUVIEN, supporting the premise of our NEW DAY Study,” said Dr. David Dyer, Alimera Sciences’ Chief Retina Specialist. “In the NEW DAY Study, we believe that ILUVIEN, due to its long-term durability and anti-inflammatory properties, can significantly reduce the need for frequent and recurring injections compared to the leading anti-VEGF.”
These data were presented during the 39th annual scientific meeting of the ASRS October 8-12, 2021, in San Antonio, Texas.
The PALADIN Study is a 3-year prospective observational Phase IV study of 0.19mg FAc (ILUVIEN) based in the US with focus on safety outcomes in patients with DME treated according to the US FDA label. The NEW DAY Study is a multicenter, single-masked, randomized, controlled trial designed to generate prospective data evaluating ILUVIEN as a baseline therapy in the treatment of DME and demonstrate its potential advantages over the current standard of care of repeat anti-VEGF (aflibercept) injections. The primary outcome measure for NEW DAY is the mean number of supplemental aflibercept injections needed during the trial between treatment groups. Key secondary endpoints include mean best corrected visual acuity (BCVA) score over time up to 18 months, time to first supplemental treatment, retinal thickness amplitude on optical coherence tomography (OCT), and diabetic retinopathy scores. Dr. Gonzalez is the principal investigator.
Full study details are available at https://clinicaltrials.gov.
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com.
The Company’s sole product is ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease and number of treatments required, enabling patients to maintain vision longer with fewer injections. ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated in the U.S. for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. For safety information please visit https://iluvien.com/#isi and scroll down the page.