New drug Iluvien approved by FDA for diabetic macular edema
Iluvien, a new drug for treating Diabetic Macular Edema has been approved by the FDA.
Diabetic macular edmea (DME) is when fluid and protein is deposited onto or under the macula. The macula is the part of the eye that provides us with our central vision. DME is the most common cause of visual impairment in people with diabetic retinopathy. Iluvien, which has the generic name fluocinolone acetonide, is a form of steroid treatment that is implanted into the eye and works for three years. The implant is tiny, much smaller than a grain of rice and is implanted into the eye a needle.
Approval by the Food and Drug Administration has been a long time coming for Iluvien. The companies behind Iluvien, Alimera Sciences Inc and pSivida Corp have twice previously had approval turned down over safety concerns and the need for more data to confirm safety.
Steroids have been shown to be effective at treating diabetic macular edema but includes two important side effects. The first side effect is that it can lead to increased pressure in the eye, which is the same problem that the eye condition glaucoma causes. The other significant side effect is that it can increase the risk of cataracts (clouding of the lens).
For this reason, the FDA has approved use of Iluvien for patients that have previously been treated with corticosteroids and have not experienced a significant rise in intraocular pressure (pressure within the eye) as a result.
A key benefit of Iluvien is that once the implant is delivered into the eye, the treatment lasts for 36 months. This compares favourably with the other rival treatment for macular edema which is intraviteral (injections into the eye) of anti-VEGF medications that require a number of injections through the year.
The FDA approval of Iluvien means that people requiring treatment for DME have the of Iluvien to add to the two anti-VEGF medications available, those being Lucentis (ranibizumab) and Eylea (aflibercept).
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