Alimera Sciences announces recent meeting findings, data from PALADIN study

Alimera Sciences 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 and diabetic macular edema, injection burden and patient adherence, and efficacy and safety of ILUVIEN 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 provides long-term reduction of retinal thickness variability, which is correlated to improved visual outcomes and better disease control. 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 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. 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 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.