Data from the recent 0.19 mg FAc implant Phase 4 observational real-world study were presented at the annual American Society of Retina Specialists (ASRS) conference
ATLANTA, July 26, 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 PALADIN Phase 4 Study confirms the safety of ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant and provides a durable treatment option that reduces the frequency of recurrence for patients with diabetic macular edema (DME).
“We are very excited to have had the opportunity to have great data from our PALADIN Study of ILUVIEN presented at the recent ASRS Annual Meeting,” added Rick Eiswirth, President and CEO of Alimera. “For the last few years, we have been refocusing our messaging on the ability of ILUVIEN to treat DME consistently to gain better control. Dr. Riemann’s abstract correlating reduced retinal thickness variability and better visual acuity demonstrates the value of ILUVIEN’s CONTINUOUS MICRODOSINGTM.”
The three-year, phase IV, real-world observational PALADIN study evaluated the long-term safety of ILUVIEN for patients with DME. This study confirms the benefit of using a prior course of corticosteroid to mitigate the risk of uncontrolled IOP elevations. The study also reported secondary outcomes of vision improvement and reduction in treatment burden and retinal thickness variability.
The results were presented for two of the abstracts at the annual ASRS conference held in New York, NY from July 13 – 16, and one is available on the online demand portal and these include –
• Dr. Christopher Riemann, a vitreoretinal surgeon at the Cincinnati Eye Institute in Ohio,
presented the abstract he authored titled “Three-Year Outcomes of the PALADIN Phase IV Study: Comparison of Anatomical Metrics, Efficacy, and Treatment Burden Post FAc.”
Amongst the exploratory findings presented in these abstracts were –
“The data verify that ILUVIEN provides physicians with a much-needed tool for safe and durable treatment of DME,” said Dr. Riemann. “The ILUVIEN implant lessens the burden of care for our patients, reducing their inflammation with fewer doctor visits while maintaining or even improving their vision.”
ASRS is among the largest gatherings of retinal specialists held annually in the field of ophthalmology. Annual meeting educational content is planned by the ASRS program committee, and ASRS does not endorse, promote, approve or recommend the use of any products, devices or services.
About PALADIN
The PALADIN study is a phase 4, open-label, prospective, observational study conducted over 36 months at 41 sites across the United States. This study was designed and developed to confirm the benefit of using a prior course of corticosteroid as indicated in the ILUVIEN U.S.to mitigate the risk of uncontrolled IOP elevation. Researchers enrolled 202 eyes in 159 patients with DME who had previously received corticosteroid treatment without a clinically significant rise in IOP. All eyes were treated with ILUVIEN and patients were followed for up to 36 months. Additionally, secondary outcomes confirmed improvement in vision and reduction in treatment burden and retinal thickness variability.
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
Alimera 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.
For press inquiries: Cassy Dump for Alimera 619-971-1887 cassy.dump@precisionvh.com |
For investor inquiries: Scott Gordon for Alimera scottg@coreir.com |
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