Phase 4 PALADIN Study Confirms Positive Predictive Value of Corticosteroid Course Prior to ILUVIEN® Use for IOP Outcomes
Recently presented data further demonstrate steroid challenge is highly predictive of IOP response post-FAc regardless of steroid choice
ATLANTA, May 12, 2022 (GLOBE NEWSWIRE) -- 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 maintaining better vision longer, announced today that the phase 4 PALADIN study confirmed the benefit of using a prior course of corticosteroid as indicated in the ILUVIEN® U.S. label to mitigate the risk of uncontrolled intraocular pressure (IOP) elevation. These results were presented at the annual Association for Research in Vision and Ophthalmology (ARVO) conference held in Denver, Colorado from May 1-4, 2022.
At the ARVO conference, Christopher Fuller, MD, a vitreoretinal specialist practicing at Texas Retina Associates in Lubbock, Texas, presented “Three Year Outcomes from the PALADIN Phase IV Study: Predictive Value of Prior Steroid Challenge and Intraocular Pressure Outcomes.” David Dyer, MD, Chief Retina Specialist at Alimera and the founder of Retina Associates in Kansas City, Missouri, authored the poster “Three Year Outcomes from the PALADIN Phase IV Study: Distribution of Intraocular Pressure Outcomes by Patient Subgroup.”
“We are excited that this data from the PALADIN study further demonstrates that the steroid challenge is highly predictive of IOP response after ILUVIEN and not dependent on the steroid choice or number of dexamethasone injections prior to ILUVIEN, when it is used in accordance with our U.S. FDA label,” said Rick Eiswirth, President and CEO of Alimera. “ILUVIEN is the first, and still the only, durable therapy to treat DME, and we are pleased to continue providing physicians with a means to lessen the recurrence of DME, thereby reducing the need for frequent injections.”
The three-year PALADIN study evaluated the long-term safety and efficacy of ILUVIEN, a 0.19-mg fluocinolone acetonide (FAc) intravitreal implant, in patients with diabetic macular edema (DME). According to the abstracts presented, the study found that the steroid challenge mitigates IOP events identified in the earlier phase 3 FAME trial. The number of eyes in each IOP sub-category were comparable between baseline and post-FAc, highlighting the predictive value of the corticosteroid challenge. Eyes with better baseline vision and eyes without additional treatment had fewer IOP events compared to the full population, suggesting that using the 0.19mg FAc implant in eyes with earlier disease may minimize IOP risk while providing optimal visual benefits. The long-term visual acuity of eyes that experienced IOP events were not significantly impacted.
The study enrolled 202 eyes in 159 patients with DME who had previously been treated with a corticosteroid and had not experienced a clinically significant rise in IOP. The eyes were treated with ILUVIEN, and patients were followed for up to 36 months. During the 36 months, the IOP distribution was marginally affected, with over 96% of eyes showing a mean IOP ≤ 25 mmHg during any study visit.
Dr. Fuller’s full abstract can be accessed here.
About ILUVIEN
www.ILUVIEN.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.
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.
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