ATLANTA, Nov. 29, 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, announces findings from a recent meeting where data demonstrated a high level of agreement among retina specialists on the role of inflammation in the pathophysiology of diabetic retinopathy (DR) and diabetic macular edema (DME), injection burden and patient adherence, and efficacy and safety of ILUVIEN

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(fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant.

The company also announced analysis of data from the 36-month PALADIN study that found 0.19 mg Fluocinolone Acetonide (FAc) provides long-term reduction of retinal thickness variability (RTV), which is correlated to improved visual outcomes and better disease control. These results were made available at the annual scientific meeting of The Retina Society held in Pasadena, CA from November 2-5, 2022.

“We are excited to see a consensus in the retina community on the increasing understanding of the role of inflammation in diabetic eye disease, and the efficacy and safety of ILUVIEN in treating DME,” said Rick Eiswirth, President and CEO of Alimera. “We are also pleased to see the continuing impact of the PALADIN Study of ILUVIEN, including another abstract presented at the recent annual meeting of The Retina Society. The PALADIN Study data presented demonstrates the correlation between reduced RTV and better visual acuity, and the value of ILUVIEN’s CONTINUOUS MICRODOSING™ in controlling RTV.”

Anton Kolomeyer, MD, PhD authored a poster titled, “Fluocinolone acetonide and DME – An Expert Consensus.” To understand the level of agreement among retinal physicians in the US on the safety and efficacy of FAc in DME treatment, as well as the role of inflammation in the pathophysiology of DR and DME, researchers disseminated a survey to retina specialists. The full survey was completed by 56 physicians. The modified Likert grading scale was used to evaluate consensus.

Key Abstract Findings:

• A consensus was reached for seven of ten proposed statements. These included those related to:
  • Chronic low-grade inflammation and the associated inflammatory cytokines (VEGF, IL-6, etc.) are key drivers of DR/DME pathogenesis.
  • Steroids have broad, non-specific anti-inflammatory properties, including the downregulation of VEGF production.
  • Chronic low-grade inflammation, a result of poor glycemic control over time, can lead to neurodegenerative changes in the diabetic retina.
  • High injection burden tied to the use of short acting therapies may lead to patient fatigue and lack of adherence, thereby limiting treatment efficacy.
  • High injection burden and poor patient adherence can lead to increased amplitude and frequency of retinal fluctuations, which may lead to irreversible vision loss in some patients.
  • The 0.19 mg fluocinolone acetonide implant can minimize retinal thickness fluctuations and reduce treatment burden through continuous and consistent treatment over 36 months.
  • IOP elevation associated with the 0.19 mg fluocinolone acetonide implant is manageable in the majority of cases with topical IOP lowering therapy.
• Although below the consensus threshold, physicians were in high agreement that “the 0.19 mg fluocinolone acetonide implant may represent a viable treatment option to establish early baseline control of the underlying low-grade, chronic inflammatory disease in patients with DR/DME,” and 93% of clinicians identified at least one clinical situation in which they would consider the use of steroids as baseline therapy.

Veeral Sheth, MD, MBA presented the abstract titled, “The 0.19 mg Fluocinolone Acetonide (FAc) Implant Reduces the Recurrence of Edema by Providing Long-Term Control of Retinal Thickness Variability in Patients with DME: The 3-Year PALADIN Study.” According to the abstract, data from the PALADIN phase IV, real world observational study support that the FAc implant significantly reduces RTV through reduction of the recurrence of edema. The authors point out that no new safety signals were identified during the Study, and they highlight the FAc implant as the only long-term therapy providing consistent control of RTV in patients with DME.

Key Abstract Findings:

• FAc provides reduction of RTV for up to 36 months
• Reduced RTV is correlated to improved visual outcomes and better disease control
• Eyes in which RTV was best controlled (Q1 & Q2) post-Fac, demonstrated significant gains in BCVA
• The 0.19 mg FAc implant provides a durable treatment option that can reduce the burden of care for patients with DME

About PALADIN


The PALADIN study was 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. label, 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

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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


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