Home Medizin Langzeitimplantat für diabetisches Makulaödem verfügbar

Langzeitimplantat für diabetisches Makulaödem verfügbar

von NFI Redaktion

The National Institute for Health and Care Excellence (NICE) has issued final guidelines recommending that patients being treated for vision impairment due to chronic diabetic macular edema (DME) have access to an intravitreal implant containing 0.19 mg fluocinolone acetonide (FAc) (Iluvien, Alimera Sciences), regardless of whether they have a natural or artificial lens.

The implant is recommended as an option when the disease has not responded adequately to available treatments, and only if the company provides it under the commercial agreement.

Until now, only patients with an artificial lens (pseudophakic eye) had access to the FAc implant, which is the only long-term treatment for chronic DME lasting up to 36 months.

In the United Kingdom, DME remains a significant issue affecting approximately 20% of individuals with type 1 diabetes and 14-25% of individuals with type 2 diabetes. The diabetes screening program in the UK has shown that the cumulative 5-year incidence of any diabetic retinopathy in type 2 diabetes was 36%, proliferative diabetic retinopathy 0.7%, and DME 0.6%, which roughly doubled after 10 years.

DMO is a complication of diabetes characterized by fluid accumulation in the macula, leading to blurred vision. It can occur at any stage of diabetic retinopathy, as high blood sugar damages small blood vessels in the eye over time, leading to leakage into the macula. In addition to blurred vision, the condition can also cause double vision and a sudden increase in eye floaters.

Risk factors for DMO include poor glucose control over an extended period, longer duration of diabetes, hypertension, nephropathy, hyperlipidemia, and gestational diabetes.

The standard treatment for DME-related vision impairment that does not respond to available therapies in eyes with a natural lens is intravitreal dexamethasone implant. Both FAc and dexamethasone are corticosteroid treatments.

The intravitreal FAc implant works similarly to the intravitreal dexamethasone implant and targets the same patient group. However, FAc needs less frequent replacement as it is released from the implant over a period of up to 36 months, while dexamethasone is released over a period of 6 months.

Findings from clinical studies suggest that the intravitreal FAc implant is more effective than a sham procedure. Data from real-world practice further support the clinical effectiveness observed in studies. Although the FAc implant was not directly compared to the dexamethasone implant in clinical studies, indirect comparisons indicate similar efficacy.

A cost analysis shows that the intravitreal FAc implant is more cost-effective for treating DME in eyes with a natural lens compared to the intravitreal dexamethasone implant.

The dosing schedule can be found in the summary of product characteristics for the intravitreal FAc implant.

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