ILUVEIN (FLUOCINOLONE) - SUSTAINED RELEASE STEROID IMPLANT

ILUVIEN is designed to release the drug fluocinolone acetonide for up to three years.

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Diabetic macular edema (DME) is a complication of diabetes that affects the eyes, specifically the macula, which is the central part of the retina responsible for sharp, central vision. DME occurs when fluid accumulates in the macula, leading to swelling and, subsequently, vision problems. This condition is associated with diabetic retinopathy, which is a diabetes-related eye disease.

The development of diabetic macular edema is linked to changes in the blood vessels of the retina due to long-term exposure to high blood sugar levels. Diabetes can cause damage to the small blood vessels of the retina, a condition known as diabetic retinopathy. When these blood vessels become leaky or swollen, fluid can accumulate in the macula, leading to macular edema.

Key points about diabetic macular edema include:

Symptoms: DME can cause vision problems, including blurriness or distortion in central vision. Individuals with DME may also experience difficulty reading, recognizing faces, or performing tasks that require detailed vision.

Risk Factors: The risk of developing DME is higher in individuals with diabetes, particularly those with poor blood sugar control. Other risk factors include the duration of diabetes, high blood pressure, and high cholesterol levels.

Diagnosis: Eye examinations, including a dilated eye exam and imaging tests such as optical coherence tomography (OCT), are used to diagnose and monitor DME. OCT allows for the visualization of the macula and helps assess the presence and severity of macular edema.

Treatment: The management of DME often involves addressing the underlying cause—diabetic retinopathy—and reducing macular edema. Common treatments include anti-vascular endothelial growth factor (anti-VEGF) injections (such as Eylea, Avastin, or Lucentis), laser therapy, and corticosteroid injections.

Prevention: Tight control of blood sugar levels, blood pressure, and cholesterol is crucial in preventing and managing diabetic macular edema. Regular eye examinations are also recommended for individuals with diabetes to detect and address retinal changes early on.

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ILUVIEN is an injectable, non-erodible, intravitreal steroid implant for the treatment of diabetic macular edema, a potentially blinding condition that affects approximately one million people in the U.S. alone. ILUVIEN is designed to release the drug fluocinolone acetonide for up to three years. Importantly, the device is small enough to be injected into the back of the eye with a 25 gauge needle creating a self-sealing hole. This insertion procedure is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.

Steroids can be used to treat diabetic macular edema (DME) by reducing inflammation and decreasing the permeability of blood vessels in the retina. Diabetic macular edema is characterized by the accumulation of fluid in the macula, the central part of the retina responsible for sharp, central vision. Inflammation and increased vascular permeability contribute to the development of macular edema in individuals with diabetic retinopathy.

Here’s how steroids help in the treatment of DME:

Anti-Inflammatory Effects: Steroids have potent anti-inflammatory properties. In the context of DME, inflammation is a contributing factor to the breakdown of the blood-retinal barrier, leading to fluid leakage into the macula. By suppressing inflammation, steroids help reduce the severity of macular edema.

Vasopermeability Reduction: Steroids help decrease the permeability of blood vessels. In diabetic retinopathy, the blood vessels in the retina can become leaky, allowing fluid to escape into the surrounding tissue, including the macula. Steroids act to stabilize blood vessel walls, reducing the leakage of fluid and improving the macular edema.

Modulation of Immune Response: Steroids can modulate the immune response, which is relevant in the context of diabetic retinopathy and DME. By regulating immune activity, steroids can help control inflammation and reduce the progression of diabetic macular edema.

There are different forms of steroids that can be used in the treatment of DME:

Intravitreal Steroid Injections: Steroids can be injected directly into the vitreous cavity of the eye. This allows for a concentrated dose to reach the retina and macula. Commonly used intravitreal steroids include triamcinolone acetonide.

Implantable Steroid Devices: Some steroid medications are available in sustained-release implantable devices. These devices are surgically placed in the eye and release a controlled amount of steroid over an extended period.

It’s important to note that while steroids can be effective in reducing macular edema, they are associated with potential side effects and risks. These may include an increase in intraocular pressure (leading to glaucoma), cataract formation, and the potential for systemic side effects. The choice of treatment, including the use of steroids, should be carefully considered by the treating ophthalmologist based on the individual patient’s health status, eye condition, and potential risks and benefits. Regular monitoring is typically required during and after steroid treatment to manage any side effects.

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As you can see in the accompanying graph, Iluvein improves visual acuity over a 3 year period in diabetics with macular edema compared to patients who are not treated with iluvein. This treatment lasts much longer than any injectable medication for diabetic macular edema.