Alimera Sciences fails to get FDA approval for Iluvien. Iluvien is a sustained release drug delivery system that releases a steroid into the eye for the treatment of diabetic macular edema. Alimera received the denial late last week in a letter from the FDA.
Implant Too Risky
In short, the FDA still has concerns about the safety of the new drug. Original concerns about cataract formation and IOP (intraocular pressure) still remain despite additional safety data submission. The FDA has stipulated additional clinical trials must be performed to answer the risk/benefit concerns.
Iluvien was anticipated to be the second sustained release drug for the treatment of a retinal disease. The first drug, Ozurdex, was approved by the FDA for treatment of retinal vascular occlusions (e.g. CRVO, BRVO). Ozurdex received FDA approval in 2009.
Docs Need Options for DME
Iluvien was to be indicated for the treatment of diabetic macular edema, a very common complication of patients with diabetic retinopathy. Typically, patients receive laser treatment as a first line treatment, but alternative treatments have been long needed as laser can not be performed in everyone.
Intraocular injections of steroid or anti-VEGF medications such as Avastin or Lucentis, have also been used to treat diabetic macular edema over the past several years, but the use of these agents is “off label.”
The sustained release device is injected into the eye and will release a steroid, fluocinolone, for up to 36 months. Shorter acting steroid injections have demonstrated favorable results and it was anticipated that a sustained release system might offer a realistic benefit of better drug levels and little need for reinjection.
What Does This Mean? Certainly, I am not in a position to remark about the FDA decision. There are many patients in whom laser is not an appropriate treatment. There is no FDA approved alternative. Ophthalmologists, including myself, have been using short acting steroids and anti-VEGF injections to treat these “no laser” patients.
Moreover, Iluvien would have validated sustained release drug delivery systems. Ozurdex was first and Iluvien would have been the second delivery system designed for injection into the vitreous.
A second approved product, regardless of indication, would have been a significant endorsement for injectable sustained release systems. Sustained release devices for macular degeneration (sustained release drug delivery of anti-VEGF), post-operative medications and glaucoma seem logical.