ANI Pharmaceuticals Announces NEW DAY Clinical Trial Results for ILUVIEN in Diabetic Macular Edema

Analysis reveals significant industry trends and economic implications

Release Date

2025-07-23

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

ANI Pharmaceuticals announced results from the NEW DAY clinical trial evaluating ILUVIEN (fluocinolone acetonide intravitreal implant) for diabetic macular edema (DME). The primary endpoint, mean total supplemental aflibercept injections, wasn't met in the intent-to-treat population. However, a post-hoc analysis showed a statistically significant reduction in supplemental injections in a subset of patients. Secondary endpoints demonstrated non-inferiority in visual acuity and central subfield thickness compared to aflibercept. ILUVIEN was generally well-tolerated, with a safety profile consistent with previous trials. The results suggest ILUVIEN may reduce treatment burden in DME patients.

Key Highlights

  • NEW DAY trial evaluated ILUVIEN vs. aflibercept in DME patients.
  • Primary endpoint (supplemental aflibercept injections) not met in ITT population, but statistically significant in post-hoc analysis.
  • Secondary endpoints showed non-inferiority in visual acuity and central subfield thickness.
  • ILUVIEN demonstrated a statistically significant reduction in time to first supplemental aflibercept injection.

Incidence and Prevalence

Latest Estimates of Incidence and Prevalence of Diabetic Macular Edema

Prevalence Rates by Duration of Diabetes

According to a 1985 population-based study in southern Wisconsin, the prevalence of diabetic macular edema (DME) varies significantly based on the duration of diabetes:

Recent Studies on DME Prevalence

Incidence Patterns

The relationship between DME and duration of diabetes showed two peaks of incidence: - First peak in patients with 15-20 years' duration of diabetes mellitus - Second peak in patients with >35 years' duration

Risk Factors

Multiple studies consistently identify these risk factors for DME development:

A 2019 Korean study of long-standing T2DM patients (disease duration ≥15 years) found macular edema was associated with: - Higher glycosylated hemoglobin levels (OR, 1.380; 95% CI, 1.032 to 1.845) - Use of rapid-acting insulin (OR, 5.211; 95% CI, 1.445 to 18.794)

Recent research from a 2024 study identified the GMI/GA ratio (glucose management index to glycated albumin) as a novel risk indicator for microvascular complications in T2DM, including diabetic retinopathy.

Economic Burden

Economic Burden of Treating Diabetic Macular Edema in USA and Europe

The economic burden of treating Diabetic Macular Edema (DME) remains substantial in both the United States and Europe. According to a 2024 systematic review, the management of diabetic retinopathy is becoming more advanced and effective but is highly expensive compared to other ocular diseases.

Prevalence and Cost Impact

A 2010 study found that the prevalence of DME among diabetic patients ranged from 0.85% to 12.3% across countries in the US and Europe. Patients with DME consume significantly more healthcare resources and incur higher costs compared to diabetic patients without retinal complications. The analysis revealed that increasing prevalence and severity of diabetic retinopathy are associated with higher direct and indirect healthcare expenditures.

Cost Projections in the United States

A 2022 study projected that if all US patients with center-involved DME and good baseline visual acuity received aflibercept initially, 10-year costs would reach $28.80 billion. Alternative approaches showed significantly lower costs: - Initial laser treatment: $14.42 billion - Initial observation with aflibercept added if vision worsened: $15.70 billion

These alternative strategies achieved similar visual acuity outcomes on average, suggesting potential for substantial cost savings at the societal level.

Treatment Economics and Patient Factors

A 2013 cost-effectiveness analysis demonstrated that when treatment results are equivalent, choosing less-expensive treatment options could yield cost savings of 40% to 88%. A 2020 study found that out-of-pocket costs significantly impact treatment decisions, with having a copay lowering the odds of receiving any treatment (odds ratio = 0.60).

Geographic Variations

Geographic variations in treatment patterns were observed within the US, with patients in the Northeast showing lower odds of initiating anti-VEGF treatment (OR = 0.60) and specifically bevacizumab (OR = 0.47).

Newer Treatments and Resource Constraints

A 2024 study evaluated the impact of resource constraints on the cost-effectiveness of faricimab compared with aflibercept and ranibizumab biosimilar for treating DME over a 5-year horizon. In resource-constrained hospitals: - Faricimab vs. aflibercept: avoided 12,596 delays, saved £15,108,609, and prevented loss of 60.06 quality-adjusted life years (QALYs) - Faricimab vs. ranibizumab biosimilar: avoided 18,910 delays, incurred £2,069,088 extra cost, prevented loss of 105.70 QALYs (ICER: £19,574/QALY)

Future Directions

The substantial financial burden of diabetic retinopathy necessitates a re-evaluation of current screening and management programs. The 2024 systematic review emphasized implementing effective prevention and management measures to alleviate costs and enhance patient outcomes. Revision of screening programs is crucial to improve quality of care and reduce costs, particularly given the impact of DR on working-age adults.

Study Design Parameters

Study Design Parameters and Endpoints in Key Trials for Diabetic Macular Edema

Study Designs

Patient Populations

Treatment Protocols

Treatment Frequency

Primary Endpoints

Secondary Endpoints

Trial Duration and Follow-up

Recent Findings

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